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

данные на 03 апреля 2011

RankStatusStudy
1CompletedLong Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients
Conditions:CMV Disease;   Viral Resistance;   Rejection;   Death
Intervention:
Sponsors:University of Massachusetts, Worcester;   Beth Israel Deaconess Medical Center;   Lahey Clinic;   Rhode Island Hospital
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:100
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Longitudinal;   Time Perspective: Prospective
NCT ID:NCT00225394
Other IDs:VAL031
First Received Date:September 21, 2005
Start Date:October 2003
Completion Date:July 2006
Last Updated Date:September 21, 2005
Last Verified Date:August 2005
Acronym:
Primary Completion Date:
Outcome Measure:
2CompletedCell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Condition:Transplant
Intervention:Procedure: Monitoring-blood samples drawn for CMV testing
Sponsors:University Health Network, Toronto;   The Physicians' Services Incorporated Foundation
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:150
Funded By:Other
Study Type:Observational
Study Design:
NCT ID:NCT00436384
Other IDs:05-0265-AE
First Received Date:February 15, 2007
Start Date:November 2005
Completion Date:March 2008
Last Updated Date:April 15, 2008
Last Verified Date:February 2007
Acronym:
Primary Completion Date:March 2008
Outcome Measure:
3CompletedProphylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
Conditions:DNA Virus Infection;   Herpesviridae Infections;   Cytomegalovirus Infection
Intervention:Drug: Ganciclovir
Sponsor:Lower Saxony Center for Nephrology
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:150
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:NCT00373165
Other IDs:ML19827
First Received Date:September 5, 2006
Start Date:August 2000
Completion Date:October 2003
Last Updated Date:September 12, 2006
Last Verified Date:September 2006
Acronym:
Primary Completion Date:
Outcome Measure:The impact of CMV infection on graft function, incidence of CMV infection and creatinine clearance in both study groups at month 12. long-term graft and patient survival. Neutrophil counts and creatinine clearance were measured on a regular basis.
4CompletedVICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Condition:Cytomegalovirus Infections
Interventions:Drug: valganciclovir [Valcyte];   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:325
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:NCT00431353
Other IDs:MV17973
First Received Date:February 2, 2007
Start Date:
Completion Date:August 2008
Last Updated Date:May 13, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:
Outcome Measures:Incidence of treatment success (CMV viremia BLQ);   Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia.;   AEs, laboratory parameters, appearance of ganciclovir resistance.
5RecruitingStudy of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Conditions:Infections, Cytomegalovirus;   Transmission of Cytomegalovirus Infection From Pregnant Woman to Foetus
Interventions:Procedure: Blood sample;   Procedure: Cord blood sample;   Procedure: Saliva swab;   Procedure: Urine sampling;   Procedure: Vaginal swab
Sponsor:GlaxoSmithKline
Gender:Female
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:90
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
NCT ID:NCT01251744
Other IDs:113134
First Received Date:November 30, 2010
Start Date:December 2010
Completion Date:March 2015
Last Updated Date:January 28, 2011
Last Verified Date:December 2010
Acronym:
Primary Completion Date:March 2015
Outcome Measures:Occurrence of congenital CMV infection in newborns or foetuses of subjects who had a confirmed primary CMV infection during pregnancy.;   Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints.;   Assessment of antibody responses to CMV of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints.;   Assessment of the cell-mediated immune responses of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints.
6Unknown Influence of Persistent CMV-Infection on Immune Senescence
Condition:Immune Senescence
Intervention:Biological: Vaccination against TBEV (FSME Immun CC)
Sponsors:University of Zurich;   Division of Infectious Diseases and Hospital Epidemiology
Gender:Both
Group:Senior
Phase:Phase IV
Number Enrolled:120
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
NCT ID:NCT00461695
Other IDs:CYTEL-Protocol V1.A1
First Received Date:April 17, 2007
Start Date:May 2007
Completion Date:December 2008
Last Updated Date:June 5, 2008
Last Verified Date:June 2008
Acronym:
Primary Completion Date:August 2008
Outcome Measures:Geometric mean titer (GMT) of anti-TBEV-antibodies measured by TBEV-neutralisation assay and ELISA one month after each TBEV-vaccine administration in the group of CMV-seropositive versus CMV-seronegative individuals;   Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).;   Safety of TBEV-vaccination in healthy elderly individuals.
7CompletedComparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase IV
Number Enrolled:300
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000894
Other IDs:ACTG 350
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 22, 2011
Last Verified Date:June 2003
Acronym:
Primary Completion Date:June 2000
Outcome Measure:
8RecruitingIn UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir
Conditions:Viral Disease;   Cytomegalovirus Infection
Interventions:Drug: Valacyclovir (ZELITREX);   Drug: Placebo
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Female
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:164
Funded By:Other
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:NCT01037712
Other IDs:P070115
First Received Date:December 21, 2009
Start Date:September 2009
Completion Date:June 2013
Last Updated Date:February 23, 2011
Last Verified Date:February 2011
Acronym:CYMEVAL
Primary Completion Date:June 2013
Outcome Measures:pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fetal infection with CMV) at 24 hours;   the viral load in the blood of the cord of the newborns infected in UTERO by CMV, the compliance at one month the criteria of tolerance;   the compliance at one month;   the criteria of tolerance
9RecruitingDetermining a Viral Load Threshold for Treating Cytomegalovirus (CMV)
Condition:Cytomegalovirus
Interventions:Drug: ganciclovir treatment or monitoring of viral load.;   Other: Monitor or treat with ganciclovir
Sponsor:Royal Free Hampstead NHS Trust
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:178
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:NCT00947141
Other IDs:6077,   REC # 6077,   Royal Free R and D # 5219,   EudraCT 2007-003472-19
First Received Date:June 12, 2009
Start Date:February 2003
Completion Date:August 2011
Last Updated Date:July 27, 2010
Last Verified Date:July 2009
Acronym:
Primary Completion Date:February 2011
Outcome Measures:Group A # with low level of CMV who develop a viral load > 3000 copies/ml & Group B # who develop a 2nd episode of a viral load above 3000 copies/ml after therapy stopped.;   To define the duration of antiviral therapy needed to treat CMV viraemia. To record the rate of increase in viral load prior to starting preemptive therapy & to correlate viral loads with CMV specific immune function.
10CompletedResponse of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status
Condition:Influenza
Intervention:Biological: Fluarix
Sponsors:Health Protection Agency, United Kingdom;   Royal Free and University College Medical School
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:100
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00442975
Other IDs:CMVfluvaccinees,   EudraCT No: 2006-006563-23
First Received Date:March 2, 2007
Start Date:March 2007
Completion Date:September 2007
Last Updated Date:July 9, 2008
Last Verified Date:February 2008
Acronym:CMVflu
Primary Completion Date:
Outcome Measure:Response to influenza vaccination (HI)
11Unknown Valganciclovir to Reduce T Cell Activation in HIV Infection
Conditions:HIV Infections;   Cytomegalovirus Infections
Intervention:Drug: valganciclovir 900mg daily vs. placebo x 8 weeks
Sponsor:University of California, San Francisco
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00264290
Other IDs:H10775-26933-01,   SFGH GCRC #976,   5 P30 AI 27763 - Hunt,   Roche VAL 104
First Received Date:December 9, 2005
Start Date:August 2006
Completion Date:March 2008
Last Updated Date:April 17, 2007
Last Verified Date:September 2006
Acronym:
Primary Completion Date:
Outcome Measures:Change in T cell activation at week 8.;   Change in CMV-specific T cell responses at week 8.;   Change in CMV DNA shedding at week 8.;   Change in CD4 counts and plasma HIV RNA levels at week 8.;   Change in all of the above factors after a 4-week washout period.
12CompletedA Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:112
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002125
Other IDs:020H,   93-FOS-31
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:June 1997
Acronym:
Primary Completion Date:
Outcome Measure:
13CompletedValganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
Condition:Cytomegalovirus Infection
Intervention:Drug: Single arm (ganciclovir and valganciclovir)
Sponsors:Hospital Universitari de Bellvitge;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:21
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:NCT00730769
Other IDs:VALGAN-03
First Received Date:August 5, 2008
Start Date:March 2004
Completion Date:July 2008
Last Updated Date:December 1, 2008
Last Verified Date:November 2008
Acronym:
Primary Completion Date:July 2007
Outcome Measures:Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).;   Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.;   Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.
14TerminatedGanciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Conditions:Acute Renal Failure;   Cytomegalovirus Infections;   Multi Organ Failure
Intervention:Drug: intravenous (IV) ganciclovir
Sponsor:University of Oslo School of Pharmacy
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:6
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00264368
Other IDs:GCV-PRISMA
First Received Date:December 9, 2005
Start Date:December 2005
Completion Date:June 2007
Last Updated Date:June 27, 2007
Last Verified Date:June 2007
Acronym:
Primary Completion Date:
Outcome Measures:comparing the total clearance with the RRT derived clearance of GCV;   comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients;   comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.;   determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine
15CompletedValganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients
Condition:Kidney Trasplant
Intervention:Drug: Valganciclovir
Sponsor:National Institutes of Health Clinical Center (CC)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:12
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00034385
Other IDs:020168,   02-CC-0168
First Received Date:June 19, 2006
Start Date:April 2002
Completion Date:October 2009
Last Updated Date:May 12, 2010
Last Verified Date:August 2008
Acronym:
Primary Completion Date:January 2007
Outcome Measure:
16Unknown Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
Condition:Liver Transplantation
Intervention:Drug: oral Valganciclovir vs oral Ganciclovir
Sponsor:Oregon Health and Science University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:200
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Cross-Sectional;   Time Perspective: Retrospective/Prospective
NCT ID:NCT00364052
Other IDs:VAL109
First Received Date:August 11, 2006
Start Date:August 2006
Completion Date:January 2007
Last Updated Date:August 16, 2006
Last Verified Date:August 2006
Acronym:
Primary Completion Date:
Outcome Measure:
17RecruitingIndividually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
Condition:Kidney Transplantation
Interventions:Drug: individual adapted immunosuppression;   Drug: golden standard therapy
Sponsors:University Hospital, Ghent;   nv Roche sa
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:128
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:NCT00895206
Other IDs:2008/640
First Received Date:May 7, 2009
Start Date:May 2009
Completion Date:May 2012
Last Updated Date:October 14, 2010
Last Verified Date:October 2010
Acronym:CD4-01
Primary Completion Date:May 2012
Outcome Measures:Graft function as measured by Cr EDTA AUC;   Graft survival;   Patient survival;   Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault);   Frequency of biopsy proven acute rejection episodes;   Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice).;   Incidence of rejection treated by antibodies (OKT3, ATG);   Time to first rejection (days);   Severity of rejection as assessed by BANFF 2005 score;   Number of acute rejections per patient;   Plasma creatinine and eGFR;   Measured GFR;   Proteinuria;   Incidence and score of borderline changes and acute rejection;   Incidence and score of chronic alloimmune injury/rejection and nonimmune injury;   Development and evolution of glucose abnormalities;   blood pressure;   ambulatory 24-hr blood pressure monitoring;   Left ventricular mass assessed by echocardiography;   Fasting lipid profile;   CMV infection (as measured with whole blood PCR) and disease;   Polyoma virus replication as measured by whole blood PCR;   Incidence of BK nephritis;   Incidence of PTLD and Nonmelanoma skin cancer;   Incidence of EBV reactivation (as measured with whole blood PCR)
18RecruitingStudy of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)
Condition:Recurrent Hepatitis C After Liver Transplantation
Intervention:Drug: mycophenolate to sirolimus switch
Sponsor:London Health Sciences Centre
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01134952
Other IDs:UWO12961
First Received Date:May 27, 2010
Start Date:June 2010
Completion Date:June 2011
Last Updated Date:August 3, 2010
Last Verified Date:May 2010
Acronym:
Primary Completion Date:December 2010
Outcome Measures:Hepatitis C viral load;   Epstein Barr virus (EBV) levels;   Cytomegalovirus (CMV) levels
19RecruitingMontelukast in Bronchiolitis Obliterans Syndrome
Conditions:Bronchiolitis Obliterans;   Lung Transplantation;   Graft Rejection
Intervention:Drug: Montelukast
Sponsors:Universitaire Ziekenhuizen Leuven;   Katholieke Universiteit Leuven
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT01211509
Other IDs:MLK002
First Received Date:September 28, 2010
Start Date:October 2010
Completion Date:October 2015
Last Updated Date:October 15, 2010
Last Verified Date:October 2010
Acronym:MLK002
Primary Completion Date:October 2014
Outcome Measures:survival/retransplantation rate after diagnosis of BOS;   survival/retransplantation rate at 2 years after diagnosis;   Obstructive and restrictive pulmonary function evolution;   Bronchoalveolar lavage fluid (BAL);   peripheral blood;   Cytomegalovirus (CMV) and non-CMV infection rates;   Acute rejection and lymphocytic bronchiolitis rates
20CompletedEfficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
Condition:Renal Transplantation
Intervention:Drug: Everolimus
Sponsor:Novartis
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:20
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: Prevention
NCT ID:NCT00170820
Other IDs:CRAD001AFR04
First Received Date:September 9, 2005
Start Date:February 2005
Completion Date:
Last Updated Date:February 6, 2007
Last Verified Date:February 2007
Acronym:
Primary Completion Date:
Outcome Measures:Renal function at M6 (glomerular filtration and tubular function).;   Renal function (other tubular function parameters);   Incidence of biopsy-proven acute rejections and CMV infections;   Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH;   Mucous and cutaneous disorders;   Adverse events and serious adverse events, premature study treatment discontinuations.;   Monitoring of everolimus trough levels.

RankStatusStudy
21Not yet recruitingAntiviral Treatment of Chronic Lymphocytic Leukemia
Condition:Chronic Lymphocytic Leukemia
Intervention:Drug: Valganciclovir
Sponsor:Medical University of Vienna
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:20
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:NCT01255644
Other IDs:EudraCT_2010-021786-78
First Received Date:December 6, 2010
Start Date:December 2010
Completion Date:
Last Updated Date:December 6, 2010
Last Verified Date:November 2010
Acronym:VGCV-CLL
Primary Completion Date:March 2013
Outcome Measure:Leukocyte count
22RecruitingStudy Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis
Condition:Steroid-refractory Severe Attack of Ulcerative Colitis
Intervention:Drug: CYCLOSPORINE VS INFLIXIMAB
Sponsor:Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:110
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:NCT00542152
Other IDs:2006-005299-42
First Received Date:October 8, 2007
Start Date:June 2007
Completion Date:June 2010
Last Updated Date:September 11, 2009
Last Verified Date:September 2009
Acronym:CYSIF
Primary Completion Date:June 2007
Outcome Measures:% of patients with treatment failure defined as: absence of clinical response at D7 or absence of remission without steroids at D98 or relapse or severe adverse event leading to treatment interruption or colectomy or fatality between D0 and D98;   % of patients in clinical response % patients in remission Lichtiger Index score MDAI score Time to discharge Endoscopic response colectomy rate Steroid dosage. Number of adverse events CMV infection
23Enrolling by invitationA Study of Thymoglobulin and Tacrolimus in Liver Transplant
Conditions:Liver Transplantation;   Liver Disease;   Immunosuppression
Interventions:Drug: anti-thymocyte globulin (rabbit);   Drug: tacrolimus
Sponsors:University of Nebraska;   Genzyme
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:100
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:NCT00564538
Other IDs:424-07
First Received Date:November 27, 2007
Start Date:December 2007
Completion Date:December 2009
Last Updated Date:November 27, 2007
Last Verified Date:November 2007
Acronym:thymo
Primary Completion Date:
Outcome Measures:Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters;   patient and graft survival, incidence of acute rejection, incidence of active CMV disease, incidence of other infections, any adverse events or serious adverse events associated with the use of thymo induction therapy
24RecruitingHemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Conditions:Fracture Fixation;   Intra-Articular Fractures;   Acetabulum
Intervention:Biological: Vitagel topical surgical hemostat
Sponsor:The University of Texas Health Science Center, Houston
Gender:Both
Group:Adult
Phase:Phase IV
Number Enrolled:50
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
NCT ID:NCT01230931
Other IDs:HSC-MS-09-0654
First Received Date:October 18, 2010
Start Date:October 2010
Completion Date:July 2012
Last Updated Date:October 28, 2010
Last Verified Date:October 2010
Acronym:
Primary Completion Date:July 2012
Outcome Measures:Intra-operative blood loss;   Change in hemoglobin level;   Amount of blood products transfused.;   Wound complications
25RecruitingAn Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition:Non-Small Cell Lung Cancer
Intervention:Drug: erlotinib [Tarceva]
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:7041
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:NCT00949910
Other IDs:MO18109
First Received Date:April 15, 2009
Start Date:November 2004
Completion Date:August 2013
Last Updated Date:March 15, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:
Outcome Measures:Safety:Adverse events, serious adverse events, premature withdrawals\n\n;   Efficacy: Response rate, time to progression, survival


 

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