NCT00538265已完成4 期
Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year
研究概览
简要总结
An open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who received a first liver transplantation,
- •presenting with a qualitative or quantitative PCR positive for hepatitis C virus at time of transplantation, whatever the transaminase activity,
- •Women of childbearing potential with a negative pregnancy test,
- •Male or female patients who agree to use an effective method of contraception,
- •patients who signed a written informed consent form to participate in the study,
- •patients who are compliant and likely to follow the visits specified by the study protocol
排除标准
- •• Preoperative serious renal impairment (serum creatinine levels > 200 µmol/l),
- •repeat transplantation,
- •multiple organ transplantation,
- •transplantation performed with an organ transplant obtained from a living donor or a reduced or shared organ grafts,
- •serious concomitant disorder,
- •positive serology for HBs antigen or HIV positive at time of enrollment,
- •previous history of nonhepatic cancer (except for localized skin cancer),
- •presence of a hepatocellular carcinoma, for which the primary lesion exceeds 5 cm or is complicated by portal thrombosis or metastatic disease,
- •an investigational product or therapy administered less than one month before entry into the study.
研究组 & 干预措施
A
Active Comparator
tacrolimus + steroids
干预措施: tacrolimus (Drug)
B
Experimental
ATG+ tacrolimus without steroids in maintenance therapy
干预措施: tacrolimus, ATG (Drug)
C
Experimental
ATG+ Mycophenolate Mofetil + tacrolimus a reduced dosage without steroids in maintenance therapy
干预措施: ATG+mycophénolate mofétil+tacrolimus (Drug)
结局指标
主要结局
The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year
时间窗: 1 year
次要结局
- • Ishak's degree of activity(1 year)
- Ishak's degree of fibrosis(2 years)
研究者
研究点 (8)
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