3 фаза клинические исследования при цитомегаловирусной инфекции у взрослых и пожилых старше 66 лет


RankStatusStudy
1RecruitingCytomegalovirus - Immunoprophylactic Adoptive Cellular Therapy Study
Condition:Cytomegalovirus Infection
Interventions:Biological: Adoptive Cellular Therapy;   Drug: Best available antiviral drug therapy
Sponsors:Cell Medica Ltd;   Wellcome Trust;   Choice Pharma Ltd;   Commitum AB;   BioAnaLab
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:110
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:NCT01077908
Other IDs:CM-2008-01,   08/H0720/15,   74928896
First Received Date:February 26, 2010
Start Date:July 2008
Completion Date:
Last Updated Date:October 13, 2010
Last Verified Date:October 2010
Acronym:CMV-IMPACT
Primary Completion Date:July 2012
Outcome Measure:CMV reactivations
2Unknown Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
Condition:Cytomegalovirus Infections
Intervention:Drug: valganciclovir
Sponsors:Duke University;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:130
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00227370
Other IDs:Val038
First Received Date:September 26, 2005
Start Date:July 2003
Completion Date:January 2008
Last Updated Date:January 2, 2008
Last Verified Date:January 2008
Acronym:Valgan
Primary Completion Date:April 2008
Outcome Measures:For Enrollment Phase , using descriptive statistics, the safety and efficacy of an open label regimen that includes initial intravenous ganciclovir followed by oral valganciclovir for 3 months post transplant for patients at risk for CMV;   For Randomization Phase , determine the rate of CMV disease at one year in the short course as compared to extended prophylaxis groups in Phase II;   Determine whether prevention of CMV disease after transplantation improves clinical outcomes. The researchers will compare the rates of acute rejection, hospitalization, non-CMV infections, and survival between the 2 groups over the study period.;   Determine how treatment with valganciclovir affects quality of life (QOL) by comparing serial measures of QOL between groups;   Determine how one year of oral valganciclovir affects ganciclovir resistance by comparing the rate of resistance between the groups
3Active, not recruitingA Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Condition:Cytomegalovirus Infections
Interventions:Drug: valganciclovir [Valcyte];   Drug: Pre-emptive therapy
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:301
Funded By:Industry
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:NCT00372229
Other IDs:ML19313
First Received Date:September 5, 2006
Start Date:May 2006
Completion Date:December 2015
Last Updated Date:September 30, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:
Outcome Measures:Percentage of patients with active CMV infection, or CMV disease.;   Urine proteomic pattern;   Time to graft loss;   CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival.
4Completed 
Has Results
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Condition:Cytomegalovirus Infections
Intervention:Drug: Valganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:326
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: Treatment
NCT ID:NCT00294515
Other IDs:NT18435
First Received Date:February 21, 2006
Start Date:March 2006
Completion Date:August 2009
Last Updated Date:July 30, 2010
Last Verified Date:July 2010
Acronym:IMPACT
Primary Completion Date:August 2008
Outcome Measures:Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
5Active, not recruitingValganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Conditions:Bone Marrow Transplantation;   Cytomegalovirus
Interventions:Drug: Valganciclovir;   Drug: Acyclovir
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
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: Prevention
NCT ID:NCT00330018
Other IDs:MYS-03-HMO-CTIL
First Received Date:May 24, 2006
Start Date:February 2006
Completion Date:April 2010
Last Updated Date:September 16, 2010
Last Verified Date:August 2009
Acronym:
Primary Completion Date:April 2010
Outcome Measures:Prevention of CMV reactivation;   Occurrence of CMV disease;   Overall survival;   Occurrence of GVHD;   Occurrence of other infections
6Active, not recruitingMaribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
Condition:Cytomegalovirus Infections
Interventions:Drug: maribavir;   Drug: ganciclovir
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:348
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);   Primary Purpose: Prevention
NCT ID:NCT00497796
Other IDs:1263-301
First Received Date:July 5, 2007
Start Date:July 2007
Completion Date:
Last Updated Date:August 11, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:
Outcome Measures:CMV disease;   Incidence of CMV infection;   Incidence of graft rejection;   Incidence of retransplantation;   Mortality
7Unknown Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infections
Interventions:Drug: maribavir;   Other: placebo
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:613
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);   Primary Purpose: Prevention
NCT ID:NCT00411645
Other IDs:1263-300
First Received Date:December 12, 2006
Start Date:December 2006
Completion Date:May 2009
Last Updated Date:August 25, 2010
Last Verified Date:June 2008
Acronym:
Primary Completion Date:November 2008
Outcome Measures:CMV organ disease;   Incidence of CMV infection;   Incidence of graft-versus-host disease;   Mortality
8CompletedCytomegalovirus 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
9CompletedPreventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Valganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:350
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00006145
Other IDs:ACTG A5030,   AACTG A5030,   DAIDS-ES ID 10170
First Received Date:August 7, 2000
Start Date:
Completion Date:
Last Updated Date:February 23, 2011
Last Verified Date:August 2009
Acronym:
Primary Completion Date:February 2006
Outcome Measure:
10SuspendedEvaluation 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:
11CompletedThe Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.
Condition:Bone Marrow Stem Cell Transplant
Intervention:Drug: Valganciclovir
Sponsors:Mayo Clinic;   Hoffmann-La Roche;   Fred Hutchinson Cancer Research Center;   City of Hope National Medical Center;   University of Florida;   University of Michigan
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:20
Funded By:Other / 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:NCT00275665
Other IDs:2124-01
First Received Date:January 10, 2006
Start Date:November 2001
Completion Date:July 2007
Last Updated Date:September 11, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:July 2007
Outcome Measures:CMV disease;   Invasive bacterial and fungal infections;   The occurrence of CMV infection or the occurrence of CMV disease (whichever occurs first) between enrollment and day 270 after transplantation.;   Occurrence of CMV disease between randomization and day 270;   The occurrence of other documented clinically significant human herpesvirus infections after randomization and day 270.;   Survival to include a comparison of treatments at day 270 and day 640;   Safety-comparison of adverse events and serious adverse events that occur on the two arms during the study
12CompletedA Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000698
Other IDs:TX 303
First Received Date:November 2, 1999
Start Date:
Completion Date:August 2007
Last Updated Date:September 26, 2008
Last Verified Date:April 1992
Acronym:
Primary Completion Date:
Outcome Measure:
13Unknown Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Valganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:500
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00017784
Other IDs:268C,   ML16356
First Received Date:June 11, 2001
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:June 2001
Acronym:
Primary Completion Date:
Outcome Measure:
14CompletedPhase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Conditions:HIV Infections;   Gastrointestinal Diseases
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:145
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Primary Purpose: Treatment
NCT ID:NCT00002145
Other IDs:020I,   93-FOS-29
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1996
Acronym:
Primary Completion Date:
Outcome Measure:
15CompletedArtesunate in Preemptive Treatment of Human Cytomegalovirus (CMV) in Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infections
Intervention:Drug: Artesunate
Sponsors:Hadassah Medical Organization;   Institut für Klinische und Molekulare Virologie;   University of Erlangen-Nürnberg Medical School
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:20
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:NCT00284687
Other IDs:MYS-02-HMO-CTIL
First Received Date:January 31, 2006
Start Date:July 2006
Completion Date:March 2010
Last Updated Date:June 9, 2010
Last Verified Date:August 2009
Acronym:
Primary Completion Date:March 2010
Outcome Measures:Safety;   Efficacy
16TerminatedMICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus
Conditions:Cytomegalovirus Infections;   Inflammatory Bowel Diseases
Intervention:Drug: Valganciclovir
Sponsor:University Hospital, Grenoble
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00237653
Other IDs:DCIC 03 21
First Received Date:October 11, 2005
Start Date:February 2004
Completion Date:December 2007
Last Updated Date:April 2, 2009
Last Verified Date:April 2009
Acronym:
Primary Completion Date:
Outcome Measures:Improvement of Crohns disease activity index score;   Diminution or disappearance of gravity criteria;   Endoscopy: improvement in appearance of lesions, or healing;   Anatomopathology: improvement of histological criteria, or total regression;   Anatomopathology: disappearance of viral infection criteria;   Virology: reversal of CMV IgG serology and PCR results
17RecruitingPrevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
Conditions:Heart Transplantation;   Cardiac Allograft Vasculopathy;   Cytomegalovirus Infection
Interventions:Drug: Pre-emptive strategy with valganciclovir plus everolimus;   Drug: Prophylaxis with valganciclovir plus mycophenolate;   Drug: Prophylaxis with valganciclovir plus everolimus;   Drug: Pre-emptive mycophenolate
Sponsor:University of Bologna
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:100
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00966836
Other IDs:PROTECT 2008-006980-35
First Received Date:August 26, 2009
Start Date:April 2009
Completion Date:
Last Updated Date:August 26, 2009
Last Verified Date:August 2009
Acronym:PROTECT
Primary Completion Date:April 2012
Outcome Measures:Change in maximal intimal thickness;   CMV infection
18CompletedPhase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Sargramostim;   Drug: Ganciclovir
Sponsor:Schering-Plough
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002070
Other IDs:005A,   C88-059
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:May 1991
Acronym:
Primary Completion Date:
Outcome Measure:
19CompletedTrial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Condition:Cytomegalovirus Infections
Interventions:Drug: Oral Valganciclovir;   Drug: IV Ganciclovir
Sponsor:Washington University School of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:120
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00241345
Other IDs:04-0274
First Received Date:October 17, 2005
Start Date:March 2004
Completion Date:February 2008
Last Updated Date:February 3, 2009
Last Verified Date:February 2009
Acronym:
Primary Completion Date:
Outcome Measures:The study end point for statistical purposes will be clearance of CMV viremia at 4 weeks from the start of therapy. Clearance of CMV viremia will be defined as a CMV viral load less than 5,000 copies/ml of whole blood.;   All patients will be followed for 6 months after randomization.
20CompletedStudies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Intervention:Drug: MSL-109
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000135
Other IDs:NEI-34
First Received Date:September 23, 1999
Start Date:September 1995
Completion Date:August 1996
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:

RankStatusStudy
21CompletedA Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00002377
Other IDs:WV15376
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 1, 2005
Last Verified Date:July 2005
Acronym:
Primary Completion Date:
Outcome Measure:
22CompletedStudies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Interventions:Drug: Foscarnet;   Drug: Ganciclovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000136
Other IDs:NEI-35
First Received Date:September 23, 1999
Start Date:March 1990
Completion Date:October 1991
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
23CompletedStudies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Device: Ganciclovir Intraocular Device;   Drug: Ganciclovir;   Drug: Cidofovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000143
Other IDs:NEI-42
First Received Date:September 23, 1999
Start Date:May 1997
Completion Date:
Last Updated Date:March 18, 2010
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
24Active, not recruitingThymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Conditions:Acute Myeloblastic Leukemia;   Lymphoblastic Leukemia;   Myelodysplasia;   Chronic Myeloid Leukemia;   Myelofibrosis;   Lympho-proliferative Diseases
Interventions:Drug: Alentuzumab;   Drug: Globulina antilinfocitaria
Sponsor:Gruppo Italiano Trapianto di Midollo Osseo
Gender:Both
Group:Adult
Phases:Phase II / Phase III
Number Enrolled:100
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:NCT00354120
Other IDs:EudraCT:2005-000805-68
First Received Date:July 19, 2006
Start Date:March 2005
Completion Date:
Last Updated Date:October 30, 2009
Last Verified Date:October 2009
Acronym:GLOBAL
Primary Completion Date:November 2008
Outcome Measures:Overall Survival;   Event Free Survival and Disease Free Survival;   Safety:;   Major infective complications (CMV and EBV related PTLD);   Acute and chronic GvHD;   Haematological and immunologic reconstitution;   Incidence of CMV and EBV reactivation;   Other infective complications;   Other toxicities;   Need for DLI
25CompletedStudies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Intervention:Drug: Cidofovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000142
Other IDs:NEI-41
First Received Date:September 23, 1999
Start Date:April 1994
Completion Date:February 1996
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
26CompletedThe Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Levocarnitine;   Drug: Adefovir dipivoxil;   Drug: Adefovir dipivoxil placebo
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:505
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
NCT ID:NCT00001082
Other IDs:CPCRA 039
First Received Date:November 2, 1999
Start Date:December 1996
Completion Date:August 1999
Last Updated Date:August 6, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:January 1999
Outcome Measure:Morbidity
27CompletedA Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Valacyclovir hydrochloride;   Drug: Acyclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Glaxo Wellcome
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:1200
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001038
Other IDs:ACTG 204,   FDA 104C
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 28, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:May 1996
Outcome Measure:
28RecruitingRandomized 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
29CompletedA Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:180
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000688
Other IDs:ACTG 071,   RS-21592,   ICM 1697
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:October 1990
Acronym:
Primary Completion Date:February 1995
Outcome Measure:
30CompletedStudies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Conditions:HIV Infections;   Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Interventions:Drug: Ganciclovir;   Drug: Foscarnet
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000134
Other IDs:NEI-33
First Received Date:September 23, 1999
Start Date:December 1992
Completion Date:March 1995
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
31CompletedMelphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Conditions:Multiple Myeloma;   Diagnosis
Intervention:Procedure: Autologous transplantation
Sponsor:Azienda Ospedaliera San Giovanni Battista
Gender:Both
Group:Adult
Phase:Phase III
Number Enrolled:298
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:NCT00950768
Other IDs:GISMM2001
First Received Date:July 31, 2009
Start Date:February 2002
Completion Date:June 2009
Last Updated Date:July 31, 2009
Last Verified Date:July 2009
Acronym:
Primary Completion Date:May 2009
Outcome Measures:Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.;   Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.
32Not yet recruitingStudy Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Condition:Allogeneic Stem Cell Transplantation
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsors:Pierrel Research Europe GmbH;   Roche Pharma AG
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:212
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01185223
Other IDs:ML 22371
First Received Date:August 18, 2010
Start Date:September 2010
Completion Date:
Last Updated Date:August 18, 2010
Last Verified Date:August 2010
Acronym:CONVINCE
Primary Completion Date:December 2012
Outcome Measures:Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir;   Combined secondary endpoint of efficacy and safety
33CompletedGanciclovir Implant Study for Cytomegalovirus Retinitis
Conditions:HIV Infections;   Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Intervention:Device: Sustained-Release Intraocular Drug Delivery System
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Primary Purpose: Treatment
NCT ID:NCT00000118
Other IDs:NEI-14
First Received Date:September 23, 1999
Start Date:October 1992
Completion Date:December 1993
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
34RecruitingSirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD)
Conditions:Leukemia, Myelocytic, Acute;   Leukemia, Lymphocytic, Acute;   Leukemia, Myeloid, Chronic;   Myelodysplastic Syndromes
Interventions:Drug: Tacrolimus/methotrexate;   Drug: Tacrolimus/sirolimus
Sponsors:National Heart, Lung, and Blood Institute (NHLBI);   Blood and Marrow Transplant Clinical Trials Network;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult
Phase:Phase III
Number Enrolled:312
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:NCT00406393
Other IDs:385,   BMT CTN 0402,   U01 HL069294-05
First Received Date:November 30, 2006
Start Date:November 2006
Completion Date:August 2013
Last Updated Date:February 24, 2011
Last Verified Date:February 2011
Acronym:BMT CTN 0402
Primary Completion Date:August 2011
Outcome Measures:Rate of Grades II-IV acute GVHD-free survival;   Time to neutrophil engraftment;   Incidence of acute GVHD;   Mucositis severity;   Time to discharge after transplant;   Infections;   Cytomegalovirus (CMV) reactivation and thrombotic microangiopathy;   Malignant disease relapse
35RecruitingNon-inferiority Study of the Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Patients
Condition:Kidney Transplant
Interventions:Drug: Everolimus and tacrolimus;   Drug: CellCept® and tacrolimus
Sponsor:Novartis
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:590
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01025817
Other IDs:CRAD001AUS92
First Received Date:November 19, 2009
Start Date:December 2009
Completion Date:
Last Updated Date:January 3, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Composite efficacy failure rates demonstrated by treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up;   To compare renal function outcome (GFR (glomerular filtration rate)) of everolimus with low dose tacrolimus regimen to that of CellCept® with standard dose tacrolimus regimen;   Incidence of CMV (viremia, syndrome and disease) and BKV (viremia, viruria, or nephropathy);   Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant;   Incidence of chronic kidney disease with associated proteinuria;   Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events
36TerminatedWP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients
Condition:Kidney Transplant
Intervention:Drug: Valganciclovir
Sponsors:University of Pittsburgh;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:5
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00275314
Other IDs:IRB # 0512007
First Received Date:January 9, 2006
Start Date:February 2006
Completion Date:April 2006
Last Updated Date:December 16, 2008
Last Verified Date:December 2008
Acronym:
Primary Completion Date:
Outcome Measures:The primary objective of the study is to determine bioequivalence of ganciclovir from the;   Valganciclovir tutti-frutti syrup formulation and the 450 mg tablet formulation at a dose of 900 mg administered in the fed state.;   The secondary objective is to compare the systemic exposure to ganciclovir from the;   Valganciclovir strawberry syrup formulation with the valganciclovir tutti-frutti syrup formulation at a dose of 900mg.
37RecruitingEffects 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
38Active, not recruiting 
Has Results
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Condition:Breast Neoplasms
Interventions:Drug: Sunitinib malate;   Drug: Taxotere
Sponsor:Pfizer
Gender:Female
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:594
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:NCT00393939
Other IDs:A6181064
First Received Date:October 30, 2006
Start Date:February 2007
Completion Date:April 2011
Last Updated Date:February 28, 2011
Last Verified Date:February 2011
Acronym:SUN 1064
Primary Completion Date:February 2010
Outcome Measures:Progression-Free Survival (PFS);   Percentage of Participants With Objective Response;   Duration of Response (DR);   Overall Survival (OS);   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score;   Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score;   Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score
39RecruitingA Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Condition:Breast Cancer
Interventions:Drug: bevacizumab [Avastin];   Drug: Taxane-based chemotherapy
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:2300
Funded By: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:NCT00448591
Other IDs:MO19391
First Received Date:March 16, 2007
Start Date:September 2006
Completion Date:March 2011
Last Updated Date:November 19, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:
Outcome Measures:Incidence of AEs, and SAEs related to Avastin;   Duration of survival, time to disease progression
40Active, not recruitingA Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Condition:Breast Cancer
Interventions:Drug: bevacizumab [Avastin];   Drug: Herceptin;   Drug: Docetaxel
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:398
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:NCT00391092
Other IDs:BO20231
First Received Date:October 20, 2006
Start Date:September 2006
Completion Date:January 2013
Last Updated Date:March 15, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:January 2013
Outcome Measures:Progression-free survival;   Overall survival;   Best overall response, duration of response, time to treatment failure.;   QoL, AEs, targeted events including CHF, laboratory parameters.

RankStatusStudy
41Active, not recruitingBETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab
Condition:Breast Cancer
Interventions:Drug: Docetaxel;   Drug: Trastuzumab;   Drug: Carboplatin;   Drug: Bevacizumab;   Drug: 5-Fluorouracil;   Drug: Epirubicin;   Drug: Cyclophosphamide
Sponsors:National Surgical Adjuvant Breast and Bowel Project (NSABP);   Cancer International Research Group;   Hoffmann-La Roche;   Genentech
Gender:Female
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:3509
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:NCT00625898
Other IDs:NSABP B-44-I,   CIRG (TRIO) 011,   Roche BO20906,   BETH
First Received Date:February 21, 2008
Start Date:April 2008
Completion Date:June 2021
Last Updated Date:December 13, 2010
Last Verified Date:December 2010
Acronym:BETH
Primary Completion Date:August 2012
Outcome Measures:Invasive Disease-free Survival (IDFS);   Invasive disease-free survival (IDFS) within chemotherapy cohorts;   Disease-free survival (DFS);   Overall survival (OS);   Recurrence-free interval (RFI);   Distant recurrence-free interval (DRFI);   Cardiac toxicity. Cumulative incidence of severe cardiac events defined as definite or probable cardiac death, or NYHA Class III or IV CHF;   Non-cardiac toxicity. Frequencies of adverse events categorized using the NCI CTCAE v3.0.;   Identification of biomarkers (from tumor and serum/plasma) predictive for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment for HER2-positive breast cancer as well as for cardiac toxicity
42Unknown CNI-Free de Novo Protocol in Patients Undergoing Liver Transplantation With Renal Impairment
Conditions:End Stage Liver Disease;   Impaired Renal Function
Intervention:Drug: anti-CD 25 mAb, Sirolimus, MMF
Sponsor:University of Regensburg
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:29
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:NCT00604357
Other IDs:PATRON07
First Received Date:January 17, 2008
Start Date:December 2008
Completion Date:December 2010
Last Updated Date:February 17, 2009
Last Verified Date:February 2009
Acronym:PATRON07
Primary Completion Date:December 2009
Outcome Measures:The primary endpoint is defined as the incidence of steroid-resistant acute rejection within the first 30 days after liver transplantation.;   incidence of acute rejection(s);   the number and the timing of acute rejections;   the development of renal function at 1 week, 1, 3, 6 and 12 months after liver transplantation;   liver allograft function;   infectious complications;   treatment failures defined as introduction of CNIs;   side-effects affecting the hematopoetic system;   tolerability;   impaired wound-healing;   incidence of hepatic artery thrombosis;   mortality


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