EUCTR2005-001221-28-GB进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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:
- •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
排除标准
- •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 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 the Milan criteria, defined as presence of a tumour 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)
- •Women of child-bearing potential
研究者
相似试验
进行中（未招募）
不适用
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 - REFINEDE NOVO LIVER TRANSPLANTMedDRA version: 14.1Level: HLTClassification code 10019715Term: Hepatic viral infectionsSystem Organ Class: 100000004871EUCTR2005-001221-28-ITOVARTIS FARMA300
进行中（未招募）
不适用
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. - REFINEDevelopment of liver fibrosis after transplantation for hepatitis C cirrhosis.MedDRA version: M15Level: LLTClassification code 10016648EUCTR2005-001221-28-PTovartis Pharma Services AG350
进行中（未招募）
不适用
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.Development of liver fibrosis after transplantation for hepatitis C cirrhosis.MedDRA version: M15Level: LLTClassification code 10016648EUCTR2005-001221-28-DEovartis Pharma Services AG450
进行中（未招募）
不适用
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. - REFINEDevelopment of liver fibrosis after transplantation for hepatitis C cirrhosis.MedDRA version: M15Level: LLTClassification code 10016648EUCTR2005-001221-28-ESovartis S.A.350
进行中（未招募）
不适用
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. - REFINEEUCTR2005-001221-28-CZovartis Pharma Services AG350