A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)
研究概览
简要总结
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.
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
- •Adult patients at least 18 years of age
- •Positive hepatitis C virus RNA at pre-transplantation
- •Primary, single-organ recipient (cadaveric donor)
- •Liver transplant between 10 and 16 weeks before treatment initiation
排除标准
- •Multi-organ or re-transplant recipient
- •Evidence of current hepatitis B infection
- •Seropositive for human immunodeficiency (HIV) infection
研究组 & 干预措施
1
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
1
干预措施: Copegus (Drug)
结局指标
主要结局
Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)
时间窗: 120 weeks postrandomization
Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.
次要结局
- Summary of Virologic Response(After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up)