2 фаза клинические исследования при цитомегаловирусной инфекции у взрослых и пожилых (66+)


RankStatusStudy
1Not yet recruitingAutologous Cytomegalovirus (CMV) Specific CD8+ T Cells as Treatment for CMV Reactivation
Conditions:CMV Reactivation;   Allogeneic Stem Cell Transplantation;   Autologous CMV Specific CD8+ T Cells
Interventions:Procedure: Lymphopheresis;   Procedure: CMV specific lymphocyte infusion;   Procedure: Peripheral blood for CMV DNA PCR;   Procedure: Haematology/Blood chemistry
Sponsor:Imperial College London
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:25
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01326273
Other IDs:JROHH0202
First Received Date:March 22, 2011
Start Date:June 2011
Completion Date:June 2014
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:June 2014
Outcome Measures:Response to adoptive transfer of autologous CMV-specific CD8+ T-cells;   The occurrence of subsequent CMV reactivations;   Rate of complete response;   Rate of early complete response;   Rate of subsequent CMV reactivation
2RecruitingCertican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients
Condition:Cytomegalovirus Infections
Interventions:Drug: Certican (everolimus) + valganciclovir;   Drug: Valganciclovir
Sponsor:Medical University of Vienna
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00828503
Other IDs:EudraCT: 2008-004745-28
First Received Date:January 23, 2009
Start Date:December 2008
Completion Date:June 2012
Last Updated Date:February 25, 2011
Last Verified Date:January 2009
Acronym:Certi-CMV
Primary Completion Date:December 2011
Outcome Measures:relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period;   CMV-load (copies/mL) after 1-8 weeks, in months 3, 4, 6 and 12; Time (in weeks) until the CMV-load reaches ≤600 copies/mL
3RecruitingAlternate Donor Study of Pre-Emptive Cellular Therapy
Condition:Cytomegalovirus Infection
Intervention:Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result
Sponsors:Cell Medica Ltd;   Leukaemia Lymphoma Research;   National Health Service, Blood and Transplant;   University of Birmingham
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:36
Funded By:Industry / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01220895
Other IDs:CM-2009-01
First Received Date:October 13, 2010
Start Date:October 2010
Completion Date:
Last Updated Date:February 16, 2011
Last Verified Date:February 2011
Acronym:CMV-ACE/ASPECT
Primary Completion Date:June 2012
Outcome Measure:Cytomegalovirus (CMV) specific immune reconstitution
4Unknown Adoptive Immunotherapy for CMV Disease
Condition:CMV Disease
Intervention:Biological: CMV vaccine
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00159055
Other IDs:280303-HMO-CTIL
First Received Date:September 9, 2005
Start Date:February 2004
Completion Date:
Last Updated Date:December 12, 2005
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measures:Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.;   Evaluate toxicity of the procedure.
5CompletedAccelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
Condition:Cytomegalovirus Infections
Intervention:Drug: ALVAC-CMV (vCP260)
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:38
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00353977
Other IDs:040198,   04-H-0198
First Received Date:July 18, 2006
Start Date:May 2004
Completion Date:March 2008
Last Updated Date:April 2, 2010
Last Verified Date:December 2009
Acronym:
Primary Completion Date:March 2008
Outcome Measures:Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating CMV-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors and...;   To evaluate the clinical safety profile of the ALVAC-pp65 (vCP260) vaccine when given to CMV seronegative and seropositive individuals (donors or healthy volunteers).
6RecruitingDose-escalation Study of the Safety, Tolerability and Ability of CMX001 to Prevent or Control Cytomegalovirus (CMV) Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infection
Interventions:Drug: CMX001;   Drug: Placebo
Sponsor:Chimerix
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:150
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00942305
Other IDs:CMX001-201
First Received Date:July 17, 2009
Start Date:October 2009
Completion Date:
Last Updated Date:March 18, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:October 2011
Outcome Measures:Safety endpoints include clinical assessments and laboratory values, incidence adn severity of GvHD, AEs (and SAEs). Efficacy endpoint includes lack of emergence or progression of CMV infection.;   Emergence or increase in CMV DNA, Occurrence of CMV diseasePatient drop-out and/or discontinuation rate,Trough levels of CMX001, CDV, and other metabolites,urine and/or plasma levels of AdV, BKV, or EBV DNA
7RecruitingStudy of Administration of CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM
Condition:Brain Cancer
Intervention:Drug: HER.CAR CMV-specific CTL
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01109095
Other IDs:H-24487 - HERT GBM
First Received Date:April 13, 2010
Start Date:October 2010
Completion Date:October 2031
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:HERT-GBM
Primary Completion Date:October 2016
Outcome Measures:Evaluating the safety and persistence of escalating doses CTL;   Evaluating and Measuring the effects of gene modified CTL
8RecruitingCytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant
Conditions:Stem Cell Transplantation;   Cytomegalovirus Infections
Intervention:Biological: CMV CTL infusion
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00078533
Other IDs:12683-VICTA,   VICTA
First Received Date:March 1, 2004
Start Date:April 2004
Completion Date:December 2021
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:VICTA
Primary Completion Date:December 2021
Outcome Measures:safety, toxicity and maximum tolerated dose (MTD);   Efficacy of recovery of virus-specific immunity and correlation with protection from viral reactivation/disease.
9CompletedCytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Other: CMV Specific Cytotoxic T Lymphocytes
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:47
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00673868
Other IDs:26769
First Received Date:May 1, 2008
Start Date:October 2007
Completion Date:
Last Updated Date:January 22, 2009
Last Verified Date:April 2008
Acronym:
Primary Completion Date:
Outcome Measures:The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.;   To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL;   To determine the CMV epitopes recognized by donors;   To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
10CompletedCytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Condition:Hypogammaglobulinemia
Intervention:Drug: CMV-Ig
Sponsor:The Cleveland Clinic
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:50
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00137748
Other IDs:IRB2953
First Received Date:August 29, 2005
Start Date:January 2001
Completion Date:January 2006
Last Updated Date:June 8, 2010
Last Verified Date:June 2010
Acronym:
Primary Completion Date:January 2006
Outcome Measure:CMV infection
11Active, not recruitingRecombinant CMV gB Vaccine in Postpartum Women
Condition:Cytomegalovirus Infections
Interventions:Biological: CMV gB vaccine;   Drug: MF59 adjuvant;   Drug: Placebo
Sponsors:University of Alabama at Birmingham;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:464
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00125502
Other IDs:99-038,   U01-AI-063565,   sanofi pasteur CMC00
First Received Date:July 29, 2005
Start Date:August 1999
Completion Date:February 2010
Last Updated Date:May 11, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:June 2007
Outcome Measures:Time to CMV infection.;   Rate of CMV infection in CMV gB vaccine and placebo recipients.;   Rate of congenital CMV infection in offspring of the immunized women.;   Rate of local and systemic reactions and adverse events.;   Peak levels of antibody to CMV gB and neutralizing antibody and decline in antibody levels over time.;   Lymphocyte proliferation response to gB.
12TerminatedA Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Condition:Glioblastoma Multiforme
Interventions:Drug: Fludarabine;   Drug: Cyclophosphamide;   Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:10
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00990496
Other IDs:31717,   PSHCI #09-045
First Received Date:October 5, 2009
Start Date:September 2009
Completion Date:September 2011
Last Updated Date:October 19, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:September 2011
Outcome Measures:To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.;   To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.;   To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.;   To determine safety of allogeneic CTL infusions in this patient population.
13RecruitingInjection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
Conditions:Cytomegalovirus Infections;   Adenovirus Infections
Intervention:Other: Cell therapy
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01325636
Other IDs:P090801
First Received Date:March 28, 2011
Start Date:March 2010
Completion Date:September 2012
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:CTLantiCMV
Primary Completion Date:September 2012
Outcome Measures:CMV blood viral load by PCR;   GvHa evaluation;   Evaluation of clinical signs according to interested organs (lung, liver, bowel,…);   Increase of T cells
14RecruitingT-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
Condition:Cancer
Interventions:Biological: adoptive immunotherapy;   Biological: alemtuzumab;   Biological: in vitro-treated peripheral blood lymphocyte therapy;   Drug: foscarnet sodium;   Drug: ganciclovir;   Genetic: polymerase chain reaction;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: infection prophylaxis and management;   Procedure: peripheral blood stem cell transplantation;   Procedure: standard follow-up care;   Radiation: radiation therapy
Sponsor:University Hospital Birmingham
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:78
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00986557
Other IDs:CDR0000650654,   CRC-TU-ACE-CMV,   53325562,   EU-20974
First Received Date:September 29, 2009
Start Date:September 2009
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:April 2010
Acronym:
Primary Completion Date:August 2013
Outcome Measures:CMV reactivation in the first year after ASCT measured by quantitative PCR;   CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT;   Time to CMV reactivation;   Use of antiviral therapy;   Incidence of secondary CMV reactivation and CMV disease;   Incidence of acute and chronic graft-versus-host disease
15CompletedCytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Conditions:Acute Lymphoblastic Leukemia;   Chronic Myelogenous Leukemia;   Acute Myelogenous Leukemia;   Hodgkin's Lymphoma;   Non-Hodgkin's Lymphoma;   Myelodysplastic Syndrome
Interventions:Biological: VCL-CB01;   Other: PBS
Sponsor:Vical
Gender:Both
Group:Adult
Phase:Phase II
Number Enrolled:240
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00285259
Other IDs:CB01-202
First Received Date:January 30, 2006
Start Date:January 2006
Completion Date:November 2010
Last Updated Date:December 15, 2010
Last Verified Date:July 2010
Acronym:
Primary Completion Date:November 2009
Outcome Measures:Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT;   occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
16SuspendedEvaluation of the Immunogenicity and Efficacy of the Towne Strain of CMV in Seronegative Women
Condition:Cytomegalovirus Infections
Interventions:Biological: Hepatitis A Vaccine;   Biological: Towne CMV Vaccine
Sponsors:Virginia Commonwealth University;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Group:Adult
Phases:Phase II / Phase III
Number Enrolled:180
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00201448
Other IDs:94-078
First Received Date:September 13, 2005
Start Date:
Completion Date:
Last Updated Date:April 21, 2009
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measure:
17CompletedMaribavir for Prevention of CMV After Stem Cell Transplants
Condition:Cytomegalovirus Infection
Intervention:Drug: maribavir
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:108
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00223925
Other IDs:1263-200
First Received Date:September 13, 2005
Start Date:
Completion Date:
Last Updated Date:June 19, 2006
Last Verified Date:June 2006
Acronym:
Primary Completion Date:
Outcome Measures:Safety and tolerabilty for up to 12 weeks of dosing;   Incidence of CMV infection;   Incidence of CMV disease
18CompletedTAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
Condition:Cytomegalovirus Infection
Intervention:Drug: Valganciclovir
Sponsor:PETHEMA Foundation
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:132
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00386412
Other IDs:2005-002813-19.,   TAMOVALCIR in alogenic
First Received Date:October 9, 2006
Start Date:November 2005
Completion Date:September 2009
Last Updated Date:September 17, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:September 2009
Outcome Measures:To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.;   To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
19Active, not recruitingCMV Glycoprotein B Vaccine in Allograft Recipients
Condition:Cytomegalovirus Infections
Interventions:Biological: CMV gB vaccine;   Drug: Placebo
Sponsors:University College, London;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:140
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
NCT ID:NCT00299260
Other IDs:04-107,   R01AI051355
First Received Date:March 3, 2006
Start Date:August 2006
Completion Date:September 2011
Last Updated Date:April 16, 2010
Last Verified Date:January 2008
Acronym:
Primary Completion Date:September 2009
Outcome Measures:safety;   immunogenicity;   viral load;   correlate of immune protection
20CompletedA Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:300
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000836
Other IDs:ACTG 294
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:August 1998
Acronym:
Primary Completion Date:
Outcome Measure:



RankStatusStudy
1Not yet recruitingAutologous Cytomegalovirus (CMV) Specific CD8+ T Cells as Treatment for CMV Reactivation
Conditions:CMV Reactivation;   Allogeneic Stem Cell Transplantation;   Autologous CMV Specific CD8+ T Cells
Interventions:Procedure: Lymphopheresis;   Procedure: CMV specific lymphocyte infusion;   Procedure: Peripheral blood for CMV DNA PCR;   Procedure: Haematology/Blood chemistry
Sponsor:Imperial College London
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:25
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01326273
Other IDs:JROHH0202
First Received Date:March 22, 2011
Start Date:June 2011
Completion Date:June 2014
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:June 2014
Outcome Measures:Response to adoptive transfer of autologous CMV-specific CD8+ T-cells;   The occurrence of subsequent CMV reactivations;   Rate of complete response;   Rate of early complete response;   Rate of subsequent CMV reactivation
2RecruitingCertican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients
Condition:Cytomegalovirus Infections
Interventions:Drug: Certican (everolimus) + valganciclovir;   Drug: Valganciclovir
Sponsor:Medical University of Vienna
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00828503
Other IDs:EudraCT: 2008-004745-28
First Received Date:January 23, 2009
Start Date:December 2008
Completion Date:June 2012
Last Updated Date:February 25, 2011
Last Verified Date:January 2009
Acronym:Certi-CMV
Primary Completion Date:December 2011
Outcome Measures:relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period;   CMV-load (copies/mL) after 1-8 weeks, in months 3, 4, 6 and 12; Time (in weeks) until the CMV-load reaches ≤600 copies/mL
3RecruitingAlternate Donor Study of Pre-Emptive Cellular Therapy
Condition:Cytomegalovirus Infection
Intervention:Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result
Sponsors:Cell Medica Ltd;   Leukaemia Lymphoma Research;   National Health Service, Blood and Transplant;   University of Birmingham
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:36
Funded By:Industry / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01220895
Other IDs:CM-2009-01
First Received Date:October 13, 2010
Start Date:October 2010
Completion Date:
Last Updated Date:February 16, 2011
Last Verified Date:February 2011
Acronym:CMV-ACE/ASPECT
Primary Completion Date:June 2012
Outcome Measure:Cytomegalovirus (CMV) specific immune reconstitution
4Unknown Adoptive Immunotherapy for CMV Disease
Condition:CMV Disease
Intervention:Biological: CMV vaccine
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00159055
Other IDs:280303-HMO-CTIL
First Received Date:September 9, 2005
Start Date:February 2004
Completion Date:
Last Updated Date:December 12, 2005
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measures:Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.;   Evaluate toxicity of the procedure.
5CompletedAccelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
Condition:Cytomegalovirus Infections
Intervention:Drug: ALVAC-CMV (vCP260)
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:38
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00353977
Other IDs:040198,   04-H-0198
First Received Date:July 18, 2006
Start Date:May 2004
Completion Date:March 2008
Last Updated Date:April 2, 2010
Last Verified Date:December 2009
Acronym:
Primary Completion Date:March 2008
Outcome Measures:Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating CMV-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors and...;   To evaluate the clinical safety profile of the ALVAC-pp65 (vCP260) vaccine when given to CMV seronegative and seropositive individuals (donors or healthy volunteers).
6RecruitingDose-escalation Study of the Safety, Tolerability and Ability of CMX001 to Prevent or Control Cytomegalovirus (CMV) Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infection
Interventions:Drug: CMX001;   Drug: Placebo
Sponsor:Chimerix
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:150
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00942305
Other IDs:CMX001-201
First Received Date:July 17, 2009
Start Date:October 2009
Completion Date:
Last Updated Date:March 18, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:October 2011
Outcome Measures:Safety endpoints include clinical assessments and laboratory values, incidence adn severity of GvHD, AEs (and SAEs). Efficacy endpoint includes lack of emergence or progression of CMV infection.;   Emergence or increase in CMV DNA, Occurrence of CMV diseasePatient drop-out and/or discontinuation rate,Trough levels of CMX001, CDV, and other metabolites,urine and/or plasma levels of AdV, BKV, or EBV DNA
7RecruitingStudy of Administration of CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM
Condition:Brain Cancer
Intervention:Drug: HER.CAR CMV-specific CTL
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01109095
Other IDs:H-24487 - HERT GBM
First Received Date:April 13, 2010
Start Date:October 2010
Completion Date:October 2031
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:HERT-GBM
Primary Completion Date:October 2016
Outcome Measures:Evaluating the safety and persistence of escalating doses CTL;   Evaluating and Measuring the effects of gene modified CTL
8RecruitingCytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant
Conditions:Stem Cell Transplantation;   Cytomegalovirus Infections
Intervention:Biological: CMV CTL infusion
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00078533
Other IDs:12683-VICTA,   VICTA
First Received Date:March 1, 2004
Start Date:April 2004
Completion Date:December 2021
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:VICTA
Primary Completion Date:December 2021
Outcome Measures:safety, toxicity and maximum tolerated dose (MTD);   Efficacy of recovery of virus-specific immunity and correlation with protection from viral reactivation/disease.
9CompletedCytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Other: CMV Specific Cytotoxic T Lymphocytes
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:47
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00673868
Other IDs:26769
First Received Date:May 1, 2008
Start Date:October 2007
Completion Date:
Last Updated Date:January 22, 2009
Last Verified Date:April 2008
Acronym:
Primary Completion Date:
Outcome Measures:The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.;   To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL;   To determine the CMV epitopes recognized by donors;   To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
10CompletedCytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Condition:Hypogammaglobulinemia
Intervention:Drug: CMV-Ig
Sponsor:The Cleveland Clinic
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:50
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00137748
Other IDs:IRB2953
First Received Date:August 29, 2005
Start Date:January 2001
Completion Date:January 2006
Last Updated Date:June 8, 2010
Last Verified Date:June 2010
Acronym:
Primary Completion Date:January 2006
Outcome Measure:CMV infection
11Active, not recruitingRecombinant CMV gB Vaccine in Postpartum Women
Condition:Cytomegalovirus Infections
Interventions:Biological: CMV gB vaccine;   Drug: MF59 adjuvant;   Drug: Placebo
Sponsors:University of Alabama at Birmingham;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:464
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00125502
Other IDs:99-038,   U01-AI-063565,   sanofi pasteur CMC00
First Received Date:July 29, 2005
Start Date:August 1999
Completion Date:February 2010
Last Updated Date:May 11, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:June 2007
Outcome Measures:Time to CMV infection.;   Rate of CMV infection in CMV gB vaccine and placebo recipients.;   Rate of congenital CMV infection in offspring of the immunized women.;   Rate of local and systemic reactions and adverse events.;   Peak levels of antibody to CMV gB and neutralizing antibody and decline in antibody levels over time.;   Lymphocyte proliferation response to gB.
12TerminatedA Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Condition:Glioblastoma Multiforme
Interventions:Drug: Fludarabine;   Drug: Cyclophosphamide;   Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:10
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00990496
Other IDs:31717,   PSHCI #09-045
First Received Date:October 5, 2009
Start Date:September 2009
Completion Date:September 2011
Last Updated Date:October 19, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:September 2011
Outcome Measures:To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.;   To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.;   To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.;   To determine safety of allogeneic CTL infusions in this patient population.
13RecruitingInjection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
Conditions:Cytomegalovirus Infections;   Adenovirus Infections
Intervention:Other: Cell therapy
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01325636
Other IDs:P090801
First Received Date:March 28, 2011
Start Date:March 2010
Completion Date:September 2012
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:CTLantiCMV
Primary Completion Date:September 2012
Outcome Measures:CMV blood viral load by PCR;   GvHa evaluation;   Evaluation of clinical signs according to interested organs (lung, liver, bowel,…);   Increase of T cells
14RecruitingT-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
Condition:Cancer
Interventions:Biological: adoptive immunotherapy;   Biological: alemtuzumab;   Biological: in vitro-treated peripheral blood lymphocyte therapy;   Drug: foscarnet sodium;   Drug: ganciclovir;   Genetic: polymerase chain reaction;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: infection prophylaxis and management;   Procedure: peripheral blood stem cell transplantation;   Procedure: standard follow-up care;   Radiation: radiation therapy
Sponsor:University Hospital Birmingham
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:78
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00986557
Other IDs:CDR0000650654,   CRC-TU-ACE-CMV,   53325562,   EU-20974
First Received Date:September 29, 2009
Start Date:September 2009
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:April 2010
Acronym:
Primary Completion Date:August 2013
Outcome Measures:CMV reactivation in the first year after ASCT measured by quantitative PCR;   CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT;   Time to CMV reactivation;   Use of antiviral therapy;   Incidence of secondary CMV reactivation and CMV disease;   Incidence of acute and chronic graft-versus-host disease
15CompletedCytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Conditions:Acute Lymphoblastic Leukemia;   Chronic Myelogenous Leukemia;   Acute Myelogenous Leukemia;   Hodgkin's Lymphoma;   Non-Hodgkin's Lymphoma;   Myelodysplastic Syndrome
Interventions:Biological: VCL-CB01;   Other: PBS
Sponsor:Vical
Gender:Both
Group:Adult
Phase:Phase II
Number Enrolled:240
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00285259
Other IDs:CB01-202
First Received Date:January 30, 2006
Start Date:January 2006
Completion Date:November 2010
Last Updated Date:December 15, 2010
Last Verified Date:July 2010
Acronym:
Primary Completion Date:November 2009
Outcome Measures:Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT;   occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
16SuspendedEvaluation of the Immunogenicity and Efficacy of the Towne Strain of CMV in Seronegative Women
Condition:Cytomegalovirus Infections
Interventions:Biological: Hepatitis A Vaccine;   Biological: Towne CMV Vaccine
Sponsors:Virginia Commonwealth University;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Group:Adult
Phases:Phase II / Phase III
Number Enrolled:180
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00201448
Other IDs:94-078
First Received Date:September 13, 2005
Start Date:
Completion Date:
Last Updated Date:April 21, 2009
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measure:
17CompletedMaribavir for Prevention of CMV After Stem Cell Transplants
Condition:Cytomegalovirus Infection
Intervention:Drug: maribavir
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:108
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00223925
Other IDs:1263-200
First Received Date:September 13, 2005
Start Date:
Completion Date:
Last Updated Date:June 19, 2006
Last Verified Date:June 2006
Acronym:
Primary Completion Date:
Outcome Measures:Safety and tolerabilty for up to 12 weeks of dosing;   Incidence of CMV infection;   Incidence of CMV disease
18CompletedTAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
Condition:Cytomegalovirus Infection
Intervention:Drug: Valganciclovir
Sponsor:PETHEMA Foundation
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:132
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00386412
Other IDs:2005-002813-19.,   TAMOVALCIR in alogenic
First Received Date:October 9, 2006
Start Date:November 2005
Completion Date:September 2009
Last Updated Date:September 17, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:September 2009
Outcome Measures:To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.;   To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
19Active, not recruitingCMV Glycoprotein B Vaccine in Allograft Recipients
Condition:Cytomegalovirus Infections
Interventions:Biological: CMV gB vaccine;   Drug: Placebo
Sponsors:University College, London;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:140
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
NCT ID:NCT00299260
Other IDs:04-107,   R01AI051355
First Received Date:March 3, 2006
Start Date:August 2006
Completion Date:September 2011
Last Updated Date:April 16, 2010
Last Verified Date:January 2008
Acronym:
Primary Completion Date:September 2009
Outcome Measures:safety;   immunogenicity;   viral load;   correlate of immune protection
20CompletedA Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:300
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000836
Other IDs:ACTG 294
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:August 1998
Acronym:
Primary Completion Date:
Outcome Measure:
RankStatusStudy
41RecruitingRandomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis
Conditions:Acute Hepatitis A;   Acute Hepatitis B;   Acute Hepatitis C;   Acute Hepatitis E;   Acute EBV Hepatitis;   Acute CMV Hepatitis
Interventions:Dietary Supplement: Silymarin;   Other: Lactose monohydrate
Sponsors:University of Maryland;   MADAUS GmbH;   The Egyptian Company for Blood Transfusion Services (EgyBlood);   Tanta Fever Hospital;   Banha Fever Hospital;   Alexandria University
Gender:Both
Age Groups:Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:213
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
NCT ID:NCT00755950
Other IDs:HP-00042363,   LE13K0.48
First Received Date:September 17, 2008
Start Date:October 2008
Completion Date:October 2010
Last Updated Date:February 5, 2010
Last Verified Date:January 2010
Acronym:
Primary Completion Date:August 2010
Outcome Measures:Incidence, severity and duration of Adverse Events;   Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl);   Normalization of ALT, AST, CRP and ESR;   Symptom resolution & return to normal physical activity;   In AVH patients with specific etiologies resolution of clinical signs and symptoms;   Persistence of acute HCV with progression to chronicity
42Not yet recruitingSERCA Gene Therapy Trial
Conditions:Advanced Heart Failure;   Patients That Have Received a Left Ventricular Assist Device
Interventions:Genetic: AAV6.SERCA2a;   Procedure: Placebo
Sponsors:Imperial College London;   Leducq Foundation
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:16
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00534703
Other IDs:SERCA1,   EudraCT Number: 2007-002809-48
First Received Date:September 24, 2007
Start Date:January 2010
Completion Date:December 2012
Last Updated Date:August 3, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Level and extent of gene expression measured by PCR of SERCA;   Levels of SERCA protein;   Viral DNA and RNA;   Other relevant proteins e.g. phospholamban, the sarcoplasmic reticulum calcium release channel, the Na+/Ca2+-exchanger.;   Function of isolated myocytes (depending on availability of cardiac tissue);   Left ventricular function assessed by echocardiography;   Incidence of major adverse cardiovascular events (MACE) at 30 days
43Unknown Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
Condition:Head and Neck Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsor:Aventis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:39
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003257
Other IDs:CDR0000066148,   AVENTIS-T-202,   MCC-11653,   RP-T-202,   NCI-V98-1394
First Received Date:November 1, 1999
Start Date:January 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:April 2000
Acronym:
Primary Completion Date:
Outcome Measure:
44Unknown A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Condition:B-Cell Chronic Lymphocytic Leukemia
Interventions:Drug: Fludarabine phosphate;   Drug: Alemtuzumab
Sponsors:Arbeitsgemeinschaft medikamentoese Tumortherapie;   Schering-Plough
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:28
Funded By:Other / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00565981
Other IDs:FLUSALEM
First Received Date:November 29, 2007
Start Date:March 2004
Completion Date:December 2008
Last Updated Date:June 4, 2008
Last Verified Date:June 2008
Acronym:
Primary Completion Date:October 2007
Outcome Measures:Safety and tolerability;   Complete and overall response rate;   Infections grade III, IV;   Rate of CMV reactivation;   Time to retreatment;   Overall survival;   Response in lymphatic compartments;   Molecular response/ immunologic MRD response;   Quality of Life
45Active, not recruitingNonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders
Conditions:AML;   ALL;   CLL;   Myelodysplastic Syndrome;   Non-Hodgkin's Lymphoma;   Hodgkin's Lymphoma;   Multiple Myeloma;   Aplastic Anemia;   Myeloproliferative Disorder
Intervention:Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF
Sponsors:Beth Israel Deaconess Medical Center;   Bayer
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:25
Funded By:Other / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00533923
Other IDs:2002P000219
First Received Date:September 20, 2007
Start Date:December 2002
Completion Date:
Last Updated Date:October 16, 2009
Last Verified Date:October 2009
Acronym:
Primary Completion Date:January 2007
Outcome Measures:Primary objective of study is to determine the safety of non-myeloablative allogenic stem cell transplantation from matched unrelated donors in patients with hematologic malignancies with a focus on the incidence of treatment-related mortality.;   Secondary clinical endpoints includes; incidence of graft failure or rejection; incidence and severity of acute and chronic GVHD; tumor response, and long-term overall and disease-free survival.
46CompletedA Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Fomivirsen sodium;   Drug: Ganciclovir
Sponsor:Isis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:194
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00002156
Other IDs:251B,   ISIS 2922-CS3
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:December 1998
Acronym:
Primary Completion Date:
Outcome Measure:
47CompletedOral Valganciclovir Versus Valacyclovir
Conditions:Chronic Lymphocytic Leukemia;   Leukemia
Interventions:Drug: Valganciclovir;   Drug: Valacyclovir
Sponsors:M.D. Anderson Cancer Center;   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:46
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00562770
Other IDs:ID02-666
First Received Date:November 20, 2007
Start Date:September 2003
Completion Date:July 2006
Last Updated Date:December 10, 2007
Last Verified Date:December 2007
Acronym:
Primary Completion Date:
Outcome Measures:CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT;   CMV antigenemia
48CompletedA Study to Evaluate FK778 in Kidney Transplant Patients
Conditions:Kidney Transplantation;   Renal Transplantation;   Transplantation, Renal;   Transplantation, Kidney;   Grafting, Kidney
Intervention:Drug: FK778
Sponsors:Astellas Pharma Inc;   Astellas Pharma Europe BV
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:364
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00189735
Other IDs:FG-778-02-60
First Received Date:September 12, 2005
Start Date:September 2003
Completion Date:October 2005
Last Updated Date:April 15, 2008
Last Verified Date:April 2008
Acronym:
Primary Completion Date:October 2005
Outcome Measures:Incidence of biopsy-proven acute rejection over the first 24 weeks.;   Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year;   Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year;   Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year;   Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year;   Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year;   Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year;   Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.;   Safety first 24 weeks: Patient survival;   Graft survival;   Incidence of adverse events;   Routine safety laboratory parameters;   Haemoglobin values at weeks two to six;   Leukocytes at weeks two to six;   Thrombocytes at weeks two to six;   Bilirubin at weeks two to six;   Incidence of CMV viraemia;   Incidence of Diarrhoea, Gastroenteritis and Gastritis;   Safety after 1 year:Incidence of adverse events;   Patient and graft survival
49RecruitingAlemtuzumab and Low-Dose Cyclosporine in Treating Patients With Severe Aplastic Anemia or Acquired Marrow Failure
Condition:Nonmalignant Neoplasm
Interventions:Biological: alemtuzumab;   Drug: cyclosporine
Sponsor:Federico II University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:50
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00895739
Other IDs:CDR0000639649,   UNMS-ALESAA,   EU-20927,   EUDRACT-2008-001151-22
First Received Date:May 7, 2009
Start Date:June 2006
Completion Date:
Last Updated Date:January 28, 2010
Last Verified Date:May 2009
Acronym:
Primary Completion Date:
Outcome Measures:Safety, as defined by occurrence of adverse effects;   Overall survival;   Hematologic response (partial and complete response, including time to response);   Failure-free survival (failure is defined as no response, chronic treatment-maintained response, or relapse);   Incidence of adverse effects after treatment;   Long-term safety of alemtuzumab treatment;   Time to achieve a complete hematological response;   Proportion of patients maintaining hematological response free of any treatment;   Incidence of relapse in responding patients;   Incidence of severe infections;   Requirement for IV antibiotics and antifungal therapy;   Requirement for red cell and platelet transfusion;   Incidence of CMV reactivation;   Kinetics of immune reconstitution;   Incidence of paroxysmal nocturnal hemoglobinuria (PNH) clone (lymphoid or myeloid) development;   Incidence of clonal evolution (i.e., karyotypic abnormalities or secondary myelodysplasia/leukemia)
50TerminatedA Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
Condition:Kidney Transplantation
Intervention:Drug: FK778
Sponsors:Astellas Pharma Inc;   Astellas Pharma US, Inc.
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:150
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00282230
Other IDs:03-0-165
First Received Date:January 24, 2006
Start Date:November 2003
Completion Date:
Last Updated Date:February 5, 2007
Last Verified Date:February 2007
Acronym:
Primary Completion Date:
Outcome Measures:Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.;   6 month patient and graft survival rates;   time to first biopsy confirmed acute rejection;   clinically treated acute rejection episodes;   treatment failure (up to 6 months);   renal function (SrCl and CrCl);   quantitation of CMV and polyomavirus viral load
51Not yet recruitingPilot Study of Unrelated Cord Blood Transplantation
Conditions:Leukemia, Myeloid, Acute;   Myelodysplastic Syndromes;   Leukemia, Lymphoblastic, Acute;   Lymphoma, Non-Hodgkin;   Hodgkin Disease;   Chronic Lymphocytic Leukemia
Interventions:Drug: Thiotepa;   Drug: Fludarabine;   Drug: Intravenous busulphan;   Drug: Thymoglobulin;   Drug: Ciclosporin;   Drug: Mycophenolate mofetil (MMF);   Drug: Cyclophosphamide;   Radiation: Radiotherapy;   Drug: Melphalan
Sponsor:King's College Hospital NHS Trust
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00916045
Other IDs:07CC12,   REC - 07/H0808/193,   EudraCT - 2007-001657-26
First Received Date:June 5, 2009
Start Date:June 2009
Completion Date:
Last Updated Date:June 5, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:June 2012
Outcome Measures:Treatment related mortality at day 100;   Disease free survival at one year post-transplant for each cohort;   Chimerism;   Incidence of neutrophil engraftment by day 42;   Incidence of platelet engraftment by 6 months;   Incidence of grade II-IV and III-IV acute GVHD;   Incidence of chronic GVHD during the first year;   One year overall survival for each treatment cohort;   Incidence of systemic infections;   Incidence of CMV, adenovirus and EBV activation;   Immune reconstitution;   Dynamics of EBV infection and immunity following cord blood transplantation;   The development (if any) of transplant associated post transplant lymphoproliferative disease (PTLD);   Identify any possible predictive markers for patients most at risk of PTLD development;   Quality of life;   Incidence of one year relapse or disease progression for each treatment cohort
52Unknown Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies
Condition:Hematological Malignancies
Intervention:Drug: Thymosin alpha 1
Sponsor:University Of Perugia
Gender:Both
Group:Adult
Phases:Phase I / Phase II
Number Enrolled:9
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00580450
Other IDs:(ST 1472),   ST 1472 06/01/27
First Received Date:December 21, 2007
Start Date:December 2007
Completion Date:December 2010
Last Updated Date:December 21, 2007
Last Verified Date:November 2007
Acronym:
Primary Completion Date:December 2007
Outcome Measure:Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.
53RecruitingAlemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia
Conditions:Infection;   Leukemia
Interventions:Biological: alemtuzumab;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: laboratory biomarker analysis;   Other: pharmacological study
Sponsor:German CLL Study Group
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:36
Funded By:Other
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00634881
Other IDs:CDR0000587746,   GCLLSG-CLL2I,   BAYER-GCLLSG-CLL2I,   EU-20816
First Received Date:March 12, 2008
Start Date:November 2003
Completion Date:
Last Updated Date:May 9, 2009
Last Verified Date:March 2008
Acronym:
Primary Completion Date:December 2011
Outcome Measures:Dose-limiting toxicity;   Maximum tolerated dose;   Rate of complete minimal residual disease response;   Rate of immunophenotypic remission using 4-color flow cytometry;   Rate of infections (especially CMV infections and reactivations);   Rate of severe hematologic and non-hematologic side effects;   Pharmacokinetics of alemtuzumab (after IV and subcutaneous administration);   Progression-free survival;   Overall survival;   Complete remission rate
54RecruitingAlemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas
Condition:Peripheral T-cell Lymphomas
Intervention:Drug: Alemtuzumab (Campath-1H)
Sponsors:Ontario Clinical Oncology Group (OCOG);   Sunnybrook Health Sciences Centre;   Genzyme
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:64
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00453427
Other IDs:CTA-Control-103662
First Received Date:March 27, 2007
Start Date:September 2006
Completion Date:June 2016
Last Updated Date:January 7, 2011
Last Verified Date:January 2011
Acronym:ACCAPELA
Primary Completion Date:June 2011
Outcome Measures:toxicity;   efficacy;   tumour response;   pharmacokinetic analysis;   immunological monitoring
55Active, not recruitingSirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Condition:Hematologic Diseases
Interventions:Drug: Sirolimus;   Drug: Mycophenolate Mofetil;   Drug: Carmustine;   Drug: VP-16;   Drug: cyclophosphamide
Sponsors:Stanford University;   National Institutes of Health (NIH)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:38
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01220297
Other IDs:SU-09092009-3841,   BMT209
First Received Date:November 24, 2009
Start Date:September 2009
Completion Date:October 2012
Last Updated Date:February 17, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:October 2012
Outcome Measures:Incidence of grade II-IV acute GVHD at D+100 post-transplant;   Grade III-IV acute GVHD;   Pharmacokinetics of MMF;   Veno-occlusive Disease Incidence of Infection CMV reactivation;   Chronic GVHD Disease-free and Overall Survival;   Time to neutrophil and platelet engraftment Thrombotic microangiopathy Severity of Mucositis
56CompletedA Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
Condition:HIV Infections
Interventions:Drug: Zidovudine;   Drug: Acyclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:400
Funded By:NIH
Study Type:Interventional
Study Design:Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000712
Other IDs:ACTG 063
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:December 1994
Acronym:
Primary Completion Date:November 1994
Outcome Measure:
57Active, not recruitingStem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignancies
Conditions:Leukemia;   Bone Marrow Transplantation
Interventions:Biological: therapeutic allogeneic lymphocytes;   Drug: cyclophosphamide;   Drug: cyclosporine;   Drug: etoposide;   Drug: fludarabine phosphate;   Procedure: allogeneic bone marrow transplantation;   Procedure: peripheral blood stem cell transplantation;   Radiation: radiation therapy
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:50
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00079391
Other IDs:040112,   04-H-0112
First Received Date:March 8, 2004
Start Date:January 2004
Completion Date:December 2008
Last Updated Date:May 19, 2010
Last Verified Date:September 2009
Acronym:
Primary Completion Date:December 2008
Outcome Measures:The proportion of patients who develop full donor T cell chimerism by day 30.;   Acute and chronic graft-versus-host disease. Transplant-related mortality. Overall mortality. Leukemic relapse. CMV reactivation and disease. Graft failure.
58RecruitingEffects of High Cut-off (HCO) Hemodialysis on Central Memory CD4+ T and Treg Cells in Patients With End-stage Kidney Disease
Conditions:End-Stage Kidney Disease;   CD4 T Cells;   Central Memory T Cells;   Regulatory T Cells;   Uremic Toxins
Intervention:Device: Polyamide HD membrane
Sponsors:Centre Hospitalier du Centre du Valais;   Research Unit CHCVs Hôpital de Sion Switzerland;   Immunology ICHV Sion Switzerland;   Immunology CHUV University Hospital Lausanne Switzerland;   Nephrology CHUV University Hospital Lausanne Switzerland
Gender:Both
Age Groups:Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
NCT ID:NCT01103076
Other IDs:HighCO Hemo study,   HCO study
First Received Date:April 13, 2010
Start Date:April 2010
Completion Date:August 2010
Last Updated Date:April 13, 2010
Last Verified Date:March 2010
Acronym:
Primary Completion Date:June 2010
Outcome Measures:HCO 1100 membrane effect on T CM and Tregs in patients with ESKD chronically hemodialzed;   Immunogenicity of the HB-AS04 vaccine in patients dialyzed with HCO 1100 or polyamide membranes
59Unknown Safety of a Multitherapy Regimen Containing Alemtuzumab in Children and Adolescents After Kidney Transplantation
Conditions:Kidney Failure, Chronic;   Kidney Transplantation;   Immunosuppression
Interventions:Drug: Alemtuzumab;   Drug: Tacrolimus;   Drug: Mycophenolate mofetil;   Drug: Sirolimus
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:35
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00240994
Other IDs:DAIT PC01
First Received Date:October 14, 2005
Start Date:January 2005
Completion Date:
Last Updated Date:March 26, 2009
Last Verified Date:April 2007
Acronym:
Primary Completion Date:November 2009
Outcome Measures:Proportion of participants who have graft loss or death;   Longer term patient and graft survival;   Occurrence, severity, and treatment for acute and humoral rejection;   Incidence of chronic allograft nephropathy;   Change in serum creatinine;   kidney function;   Incidence and severity of hyperlipidemia, hypertension, anemia, leukopenia, neutropenia, and the requirement for treatment;   Infectious complications, including bacterial, viral, and fungal infections;   Surgical complications;   Incidence and duration of re-hospitalizations after transplantation;   Incidence of biopsy proven post-transplant lymphoproliferative disorder (PTLD);   Incidence of opportunistic infections, especially cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viremia;   Treatment for viremia and disease;   Incidence of delayed graft function
60RecruitingSirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
Conditions:Chronic Myeloproliferative Disorders;   Leukemia;   Lymphoma;   Multiple Myeloma and Plasma Cell Neoplasm;   Myelodysplastic Syndromes;   Myelodysplastic/Myeloproliferative Neoplasms
Interventions:Biological: rituximab;   Drug: busulfan;   Drug: carmustine;   Drug: cyclophosphamide;   Drug: cytarabine;   Drug: etoposide;   Drug: fludarabine phosphate;   Drug: melphalan;   Radiation: total-body irradiation
Sponsors:Barbara Ann Karmanos Cancer Institute;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:48
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Primary Purpose: Supportive Care
NCT ID:NCT00691015
Other IDs:CDR0000597130,   WSU-2007-127,   GENZ-WSU-2007-127
First Received Date:June 4, 2008
Start Date:May 2008
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:April 2010
Acronym:
Primary Completion Date:May 2010
Outcome Measures:Incidence and severity of acute graft-versus-host disease (GVHD) within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria;   Safety, as defined by serious adverse events and adverse events related to study treatment within 6 months after PBSCT;   Incidence of chronic GVHD within 2 years after PBSCT;   Time to engraftment (i.e., absolute neutrophil recovery [ANC > 1,500/mm³] and platelet recovery [platelet count > 25,000/mm³]);   Overall and disease-free survival at 2 years after PBSCT;   Length of hospital stay within 100 days after PBSCT;   Incidence of infections, including bacterial, fungal, and viral infections (i.e., CMV and EBV reactivation, including post-transplant lymphoproliferative disorders) within 6 months after PBSCT;   lncidence of thrombotic microangiopathy within 100 days after PBSCT;   Karnofsky performance status at baseline and at 100 days, 6 months, 1 year, and 2 years after PBSCT;   Biomarkers and immunocorrelative studies (i.e., T-cell, B-cell, NK-cell, regulatory T-cell, and allo-reactive T-cell quantitation studies by flow cytometry) at 30, 60, 90, and 180 days after PBSCT

RankStatusStudy
61Unknown Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders
Conditions:Congenital Amegakaryocytic Thrombocytopenia;   Diamond-Blackfan Anemia;   Leukemia;   Myelodysplastic Syndromes;   Severe Congenital Neutropenia
Interventions:Biological: alemtuzumab;   Drug: busulfan;   Drug: cyclosporine;   Drug: fludarabine phosphate;   Drug: methotrexate;   Drug: methylprednisolone;   Procedure: allogeneic bone marrow transplantation;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: peripheral blood stem cell transplantation;   Procedure: umbilical cord blood transplantation
Sponsors:University of California, San Francisco;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:35
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00301834
Other IDs:CDR0000462406,   UCSF-04152,   UCSF-00452,   UCSF-H411-25738-02
First Received Date:March 9, 2006
Start Date:January 2005
Completion Date:
Last Updated Date:July 3, 2010
Last Verified Date:December 2008
Acronym:
Primary Completion Date:December 2010
Outcome Measures:Engraftment at 6 weeks post transplantation;   Treatment-related mortality at 100 days and 1 year post transplantation;   Toxicity grade ≥ 3 from start of conditioning through the first year post transplantation;   Cytomegalovirus (CMV) infection and disease assessed weekly for the first 3 months, then every 2 weeks until CD4 > 200;   Disease-free survival with correction of disease at one year post transplantation
62Unknown Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Condition:Diabetes Mellitus, Type 1
Interventions:Drug: hOKT3gamma1 (Ala-Ala);   Other: Intensive diabetes management
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Immune Tolerance Network
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:81
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00129259
Other IDs:DAIT ITN027AI
First Received Date:August 9, 2005
Start Date:September 2005
Completion Date:March 2011
Last Updated Date:May 13, 2009
Last Verified Date:March 2009
Acronym:AbATE
Primary Completion Date:March 2011
Outcome Measures:Change from baseline of the mean C-peptide 4-hour area under the curve (AUC) in response to a mixed meal tolerance test (MMTT);   Diabetes-related endpoints, including insulin use, time to undetectable C-peptide response, and HbA1C level;   pharmacokinetic measures, including drug levels, adverse events, Epstein-Barr virus (EBV)/cytomegalovirus (CMV) viral loads;   mechanistic assessments, including T cell depletion/repopulation, alterations to cytokine levels, and T cell activation measures
63CompletedThe Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
Conditions:Herpes Simplex;   HIV Infections;   Hepatitis B
Intervention:Drug: Fialuridine
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Oclassen Pharmaceuticals
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:78
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000654
Other IDs:ACTG 122 FIAU,   R90-001-01, 02, 03, 04
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:September 1993
Acronym:
Primary Completion Date:
Outcome Measure:
64RecruitingInducing Remission in Type 1 Diabetes With Alefacept
Condition:Diabetes Mellitus, Type 1
Interventions:Drug: alefacept;   Drug: placebo (saline)
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Immune Tolerance Network
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:66
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00965458
Other IDs:DAIT ITN045AI
First Received Date:August 22, 2009
Start Date:March 2011
Completion Date:August 2014
Last Updated Date:March 21, 2011
Last Verified Date:March 2011
Acronym:T1DAL
Primary Completion Date:August 2013
Outcome Measures:Mixed-meal tolerance test (MMTT) stimulated 2-hour C-peptide area under the curve (AUC);   MMTT-stimulated peak and 4-hour C-peptide AUC;   MMTT-stimulated 2-hour C-peptide AUC assessed;   Insulin use in units per kilogram body weight per day;   Major hypoglycemic events occurring from randomization;   HbA1C levels;   Rate of injection reactions; defined as fever, chills, headache, nausea, vomiting, and injection-site pain in participants receiving alefacept or placebo.;   Rate of hypersensitivity reactions; defined as signs and symptoms of anaphylaxis, wheezing, dyspnea, urticaria, and hypotension in participants receiving alefacept or placebo.;   Rate of evidence of infection with Epstein-Barr virus (EBV), Cytomegalovirus (CMV), or Tuberculosis (TB) in participants receiving alefacept or placebo.;   Frequency and severity of all AEs in participants receiving alefacept or placebo
65Active, not recruitingSafety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Conditions:Transplantation;   Rejection;   Alemtuzumab
Intervention:Drug: Alemtuzumab
Sponsor:University of Pittsburgh
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:23
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01208337
Other IDs:IRB0701088
First Received Date:September 22, 2010
Start Date:April 2007
Completion Date:November 2014
Last Updated Date:March 14, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:March 2010
Outcome Measure:Incidence and severity of biopsy-proven acute cellular rejection
66RecruitingAMD3100 to Mobilize Stem Cells for Donation
Conditions:Healthy;   Blood Component Removal
Intervention:Drug: AMD3100
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:25
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00075335
Other IDs:040078,   04-H-0078
First Received Date:January 8, 2004
Start Date:January 2004
Completion Date:January 2013
Last Updated Date:October 14, 2010
Last Verified Date:October 2010
Acronym:
Primary Completion Date:January 2013
Outcome Measures:To determine the CD34 plus cell content of an AMD3100 mobilized PBPC in comparison to G-CSF mobilized PBPC from the same healthy donor.;   1) Determine the CD34 plus cell mobilization kinetics following subcutaneous dose of AMD3100. 2) Yields of hematopoietic progenitor cells, immune cells, and other cellular subsets collected by apheresis; and 3) safety profile of AMD3100.
67CompletedCombined High Frequency Oscillation and Tracheal Gas Insufflation for Severe Acute Respiratory Distress Syndrome
Condition:Respiratory Distress Syndrome, Adult
Intervention:Other: High Frequency Oscillation and Tracheal Gas Insufflation
Sponsor:University of Athens
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:54
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00416260
Other IDs:10532-HFO-TGI
First Received Date:December 26, 2006
Start Date:July 2006
Completion Date:September 2007
Last Updated Date:February 23, 2009
Last Verified Date:February 2009
Acronym:
Primary Completion Date:September 2007
Outcome Measures:Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization;   Survival to days 28 and 60 post-randomization and to Hospital Discharge;   Ventilator free days;   Number of Organ or system failure free days;   Occurence of Barotraumas/airway injury
68Active, not recruitingPhase I/II Clinical Trial Combining hTERT Tumor Vaccine & Autologous T Cells in Patients With Advanced Myeloma
Condition:Multiple Myeloma
Interventions:Biological: Telomerase (hTERT vaccine + pneumoccal conjugate vaccine (PCV));   Biological: PCV vaccine
Sponsors:University of Pennsylvania;   University of Maryland
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:56
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00834665
Other IDs:UPCC 13406 / GCC610
First Received Date:January 3, 2008
Start Date:December 2006
Completion Date:December 2009
Last Updated Date:September 21, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:December 2009
Outcome Measures:Does combination therapy delay hematopoietic recovery or induce other autoimmune events.;   Does combination therapy generate cytotoxic T-cell responses to autologous myeloma cells in-vivo.
69RecruitingStudy Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Condition:Breast Neoplasms
Interventions:Drug: CP-751,871 + exemestane;   Drug: exemestane
Sponsor:Pfizer
Gender:Female
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:260
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00372996
Other IDs:A4021004
First Received Date:September 5, 2006
Start Date:February 2007
Completion Date:January 2014
Last Updated Date:March 18, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:January 2014
Outcome Measures:Efficacy of the exemestane plus CP-751,871 combination measured as Progression Free Survival;   Safety;   Clinical benefit;   PK;   Pharmacodynamics and Quality of Life Outcome
70TerminatedAutologous Stem Cell Transplant Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
Condition:Small Cell Lung Cancer
Intervention:Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Sponsor:H. Lee Moffitt Cancer Center and Research Institute
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:4
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00776295
Other IDs:MCC 14955
First Received Date:October 20, 2008
Start Date:April 2007
Completion Date:August 2010
Last Updated Date:October 4, 2010
Last Verified Date:October 2010
Acronym:
Primary Completion Date:June 2010
Outcome Measures:1-year survival from the first day of cyclophosphamide and GM-CSF mobilization to the day of death.;   p53 immunity measured by ELISPOT for interferon-y producing cells, and by p53-specific tetramer in HLA-A *0201 patients;   Tumor response/progression rates (CR, PR, PD, SD) in patients with measurable disease, as defined by RECIST criteria







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