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.

ovartis Pharma Services AG0 个研究点目标入组 450 人开始时间: 2005年12月2日最近更新: 2013年4月1日

适应症

试验速览

暂无简介。

•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)

发起方