A multicenter, randomized, open label study to compare the development of liver fibrosis after transplantation for hepatitis C cirrhosis in patients receiving either Neoral or tacrolimus. - REFINE
- Conditions
- Development of liver fibrosis after transplantation for hepatitis C cirrhosis.MedDRA version: M15Level: LLTClassification code 10016648
- Registration Number
- EUCTR2005-001221-28-BE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
•Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis
•Male or female aged 18 to 75 years
•Patients receiving a first liver transplant from deceased or living donor
•Patients willing and capable of giving written informed consent for study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
••Multi-organ transplant recipients
•Transplanted with an organ from a non-heart beating donor
•Patients receiving an ABO incompatible liver
•Expected to receive induction therapy with ATG/ALG or OKT3
•HBV/HIV co-infected patients
•Recipients of an organ from an HCV+ or HIV+ donor
•Patients who are unlikely to comply with the study requirements or unable to give informed consent
•Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer or if such therapy is to be instituted post-transplantation
•History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
•Patients transplanted for hepatocellular carcinoma exceeding 3 modules or with nodule diameter larger than 5 cm
•History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method