A multicenter, randomized, open label study to compare the development of liver fibrosis at 12 months after transplantation for hepatitis C cirrhosis in patients receiving either Neoral or tacrolimus - REFINE
- Conditions
- DE NOVO LIVER TRANSPLANTMedDRA version: 14.1Level: HLTClassification code 10019715Term: Hepatic viral infectionsSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2005-001221-28-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
¿ Male or female aged 18 to 75 (inclusive) ¿ Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis ¿ Patients receiving a first liver transplant from a deceased or living donor ¿ Patients willing and capable of giving written informed consent for study participation ¿ Patients in whom allograft biopsies will be possible ¿ Patients in whom the immunosuppressive regimen described in this protocol will be initiated and maintained for the entire study period
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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+ or HBV+ donor ¿ Patients with a serum creatinine ≥2.0 mg/dL (≥177 μmol/L) prior to transplantation or if renal dialysis is necessary prior to transplantation ¿ Patients with severe coexisting disease or presenting with any unstable medical condition which could affect the study objectives ¿ Patients who are not eligible to receive the recommended calcineurin inhibitor starting dose within 24 hours of transplantation ¿ Patients with a co-existing alcoholic disease who have not been abstinent for at least 6 month immediately prior to transplantation and are not expected to be able to remain abstinent after transplantation ¿ 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 halflives of enrollment, whichever is longer or if such therapy is to be instituted posttransplantation ¿ History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures ¿ Patients transplanted for hepatocellular carcinoma exceeding the Milan criteria, defined as presence of a tumor 5 cm or less in diameter in patients with single hepatocellular carcinoma and no more than 3 tumor nodules, each 3 cm or less in diameter in patients with multiple tumors ¿ 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 Main Objective: To demonstrate that the rate of fibrosis stage 2 or above (Ishak-Knodell FS≥2) at 1 year posttransplant is lower in hepatitis C positive patients receiving Neoral versus tacrolimus.;Secondary Objective: ¿ To compare the rate of the combined endpoint of death or graft loss or FS≥2 by 1 year post-transplant and at the 2 year follow-up visit; ¿ To compare the occurrence rate of FS≥2 at the 2 year follow-up visit ¿ To compare the mean fibrosis score at 1 and 2 years and its evolution over time in each arm ¿ To compare the percentage of patients with an increase of at least 1 stage in fibrosis between 1 and 2 years ¿ To compare the incidence of fibrosing cholestatic hepatitis by 1 year;Primary end point(s): To compare the development of liver fibrosis at 12 months after transplantation for hepatitis C cirrhosis
- Secondary Outcome Measures
Name Time Method