Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Negative viral PCR
研究概览
简要总结
In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.
详细描述
Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. In our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. At the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. Efficacy will be assessed on virological response after 30 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •First liver transplantation or retransplantation in the month after initial transplantation
- •Patients aged over 18 years
- •Post-hepatitis C cirrhosis
- •Equilibrated immunosuppressive treatment
- •Positive PCR for hepatitis C virus
- •Liver biopsy between 6 months and 5 years after the transplantation with a fibrosis Metavir score at least F1
- •Hemoglobin ≥ 10 g/dl
- •Platelet count ≥ 50.000/mm3
- •Normal TSH value
- •Serum creatinine < 200µmol/l
- •Informed written consent
排除标准
- •Chronic rejection
- •Acute rejection at inclusion
- •Multi-visceral transplantation
- •Renal or cardiac failure, severe sepsis
- •Uncontrolled diabetes
- •Positive serology for hepatitis B or HIV at inclusion
- •EBV virus replication at inclusion
- •Hepatocellular carcinoma at inclusion
- •Cirrhosis with a fibrosis Metavir score F4 at inclusion
- •Inclusion in another clinical trial less than one month ago
- •Pregnancy
- •Contra-indication to ribavirin or interferon
- •History of or current psychiatric troubles
- •Thyroid disease uncontrolled by treatment
研究组 & 干预措施
1
Ribavirin maintenance treatment
干预措施: Ribavirin (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Negative viral PCR
时间窗: 30 months
次要结局
- Histological improvement(30 months)
- Biological hepatic markers(30 months)
- Quality of life(30 months)
- Intensity, severity and delay to acute transplant rejection, histologically proven(30 months)
- Incidence of death or graft loss(30 months)
- Number of patients stopping the treatment and causes(30 months)
- Incidence of adverse events classically related to treatment(30 months)
- Incidence of adverse events possibly related to treatment(30 months)