PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,333
- 主要终点
- Sustained Virologic Response (SVR) Rate
研究概览
简要总结
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Positive for Hepatitis C
- •Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
- •Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis
排除标准
- •Any cause for the liver disease other than chronic hepatitis C
- •History or presence of complications of cirrhosis
- •Alcohol or illicit drug use or methadone treatment within the past 2 years
- •Treatment for chronic hepatitis C within the previous 6 months
- •Diseases or conditions that could interfere with the subject's participation in and completion of the study
研究组 & 干预措施
Overall study population
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Overall study population
干预措施: REBETOL (ribavirin; SCH 18908) (Drug)
结局指标
主要结局
Sustained Virologic Response (SVR) Rate
时间窗: Assessed at end of 24 weeks posttreatment follow-up
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
次要结局
- Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12(24 weeks posttreatment)
- Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12(24 weeks posttreatment)