A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,013
- 试验地点
- 26
- 主要终点
- Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
研究概览
简要总结
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 years of age
- •Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- •Documented pre-treatment HCV RNA quantitative result
- •Compensated liver disease (Child-Pugh Grade A)
- •Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
排除标准
- •Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- •Co-infection with active hepatitis A and/or hepatitis B
- •History or evidence of a medical condition associated with liver disease other than HCV
- •Signs and symptoms of hepatocellular carcinoma
- •History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- •Therapy with antineoplastic treatment </= 6 months prior to study day
- •Diabetes mellitus in subjects receiving an insulin therapy
- •Evidence of severe retinopathy
- •Pregnant or breast-feeding women, and male partners of women who are pregnant
研究组 & 干预措施
Single Arm
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Single Arm
干预措施: ribavirin [Copegus] (Drug)
结局指标
主要结局
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
时间窗: Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
时间窗: Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
时间窗: Week 12
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
时间窗: Week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
时间窗: Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
时间窗: Week 4
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
次要结局
- Percentage of Participants With pEVR to Study Treatment at Week 12(Week 12)
- Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment(Week 12)
- Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24(Week 24)