EUCTR2005-001221-28-IT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
- 300
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
- •¿ 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
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 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)
研究者
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