Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
CHASE
1 other identifier
interventional
138
8 countries
17
Brief Summary
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2005
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedApril 11, 2013
September 1, 2011
3 years
February 22, 2006
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Viral load of HCV at 12 months post transplantation
12 months
Secondary Outcomes (4)
Biopsy-proven acute rejection
12 months
Acute rejection
12 months
Patient and graft survival
12 months
Incidence of adverse events
12 months
Study Arms (2)
1
ACTIVE COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
- Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
You may not qualify if:
- Recipient of multi-organ transplant
- Recipient of an auxiliary graft
- Patient is receiving ABO incompatible graft
- Patients requiring immunosuppressive treatment
- Patients requiring ongoing corticosteroid therapy.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
- Patient or donor is known to be HIV positive.
- Patient is allergic or intolerant to study medication
- Patient is pregnant or breast-feeding.
- Patient has been previously enrolled in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Prague, 140 21, Czechia
Unknown Facility
Besançon, 25030, France
Unknown Facility
Lyon, 69317, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Villejuif, 94804, France
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Hamburg, 20251, Germany
Unknown Facility
Mainz, 55131, Germany
Unknown Facility
Bologna, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Modena, 41100, Italy
Unknown Facility
Warsaw, 02-097, Poland
Unknown Facility
Barakaldo, 48903, Spain
Unknown Facility
Madrid, 28035, Spain
Unknown Facility
Santiago, 15706, Spain
Unknown Facility
Gothenburg, 413 45, Sweden
Unknown Facility
London, SE5 9RS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Physician
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
June 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
April 11, 2013
Record last verified: 2011-09