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Trial record 38 of 65 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

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ClinicalTrials.gov Identifier: NCT00163657
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Collaborators:
Baylor Health Care System
Emory University
University of Southern California
Mayo Clinic - Scottsdale/Phoenix, Arizona
New York Presbyterian Hospital
Oregon Health and Science University
New York University
University of Cincinnati
University of Alabama at Birmingham
The University of Texas Health Science Center at San Antonio
University of Chicago
University of California, San Francisco
Mayo Clinic - Rochester, Minnesota
Medical University of South Carolina
University of Virginia
Lahey Clinic
University of Medicine and Dentistry of New Jersey
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Baylor Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions End Stage Liver Disease
Hepatitis C
Interventions Drug: Daclizumub
Drug: Tacrolimus
Drug: Cyclosporine
Drug: MMF
Enrollment 312
Recruitment Details Recruitment period August 15, 2002-March 29, 2004 Recruitment of liver transplant receipeints from centers transplant program
Pre-assignment Details Subjects must be receiving a liver transplant for end stage chronic HCV
Arm/Group Title Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Hide Arm/Group Description Immunosuppression TAC (tacrolimus) and CS (cyclosporine) Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine) Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Period Title: Overall Study
Started 80 79 153
Completed 60 56 116
Not Completed 20 23 37
Reason Not Completed
Death             12             14             19
graft loss             4             1             2
Withdrawal by Subject             2             3             2
Physician Decision             0             1             1
Non Compliance             1             0             0
Lost to Follow-up             1             3             10
Other reason             0             1             3
Arm/Group Title Treatment Arm 1 Treatment Arm 2 Treatment Arm 3 Total
Hide Arm/Group Description Immunosuppression TAC (tacrolimus) and CS (cyclosporine) Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine) Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus) Total of all reporting groups
Overall Number of Baseline Participants 80 79 153 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Years Number Analyzed 80 participants 79 participants 153 participants 312 participants
51.7  (7.2) 51.4  (7.8) 51.5  (7.4) 51.6  (7.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 153 participants 312 participants
Female
24
  30.0%
19
  24.1%
44
  28.8%
87
  27.9%
Male
56
  70.0%
60
  75.9%
109
  71.2%
225
  72.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 80 participants 79 participants 153 participants 312 participants
80
 100.0%
79
 100.0%
153
 100.0%
312
 100.0%
Reduce HCV recurrent post liver transplant   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 153 participants 312 participants
80 79 153 312
[1]
Measure Description: Patients receiving a liver transplant for chronic HCV
1.Primary Outcome
Title Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
Hide Description Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Hide Arm/Group Description:
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Overall Number of Participants Analyzed 80 79 153
Measure Type: Number
Unit of Measure: participants
69 70 133
2.Primary Outcome
Title Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
Hide Description Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence
Time Frame 12 month post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Hide Arm/Group Description:
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Overall Number of Participants Analyzed 80 79 153
Measure Type: Number
Unit of Measure: participants
39 39 72
Time Frame 24 months
Adverse Event Reporting Description biopsy, labs
 
Arm/Group Title Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Hide Arm/Group Description Immunosuppression TAC (tacrolimus) and CS (cyclosporine) Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine) Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
All-Cause Mortality
Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/80 (15.00%)      14/79 (17.72%)      14/153 (9.15%)    
General disorders       
Death   12/80 (15.00%)  12 14/79 (17.72%)  14 14/153 (9.15%)  19
Graft loss   4/80 (5.00%)  4 1/79 (1.27%)  1 2/153 (1.31%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Treatment Arm 1 Treatment Arm 2 Treatment Arm 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/80 (15.00%)      79/79 (100.00%)      153/153 (100.00%)    
General disorders       
thrombocytopenia   5/80 (6.25%)  6 40/79 (50.63%)  45 80/153 (52.29%)  85
neutropenia   3/80 (3.75%)  4 40/79 (50.63%)  45 70/153 (45.75%)  75
anemia   4/80 (5.00%)  5 40/79 (50.63%)  45 10/153 (6.54%)  13
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Goran Klintmalm, MD Director
Organization: Baylor University Medical Center
Phone: 214-820-2050
EMail: michelle.acker@baylorhealth.edu
Layout table for additonal information
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00163657     History of Changes
Other Study ID Numbers: 02-01-L
ZEN159 ( Other Identifier: Baylor Research Institute )
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: February 23, 2012
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017