PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 631
- 主要终点
- Time to Observation of the First Clinical Event Experienced by a Subject
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at entry 18-65 years;
- •Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
- •Liver biopsy demonstrating cirrhosis
排除标准
- •Any other cause for liver disease other than chronic hepatitis C;
- •History or presence of complications of cirrhosis;
- •Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
- •Diseases or conditions that could interfere with participation in the study
研究组 & 干预措施
PegIntron
PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
干预措施: peginterferon alfa-2b (SCH 54031) (Biological)
Untreated Control
结局指标
主要结局
Time to Observation of the First Clinical Event Experienced by a Subject
时间窗: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Clinical events are liver decompensation \[variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites\], hepatic carcinoma, death, and/or liver transplantation
次要结局
- Time to Observation of the Disease Progression Experienced by a Subject(Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event)