Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
研究概览
简要总结
This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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, >/= 18 years of age
- •Chronic hepatitis C
- •Measurable serum HVC RNA levels
- •Compensated liver disease (Child-Pugh class A)
- •Treatment-naive for standard or pegylated interferons, or non-responder or relapsing
排除标准
- •Concomitant hepatitis A or B
- •History of chronic liver disease not caused by hepatitis C virus
- •Hepatocellular carcinoma
- •History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
- •Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
- •Pregnant or lactating women, or men whose partners are pregnant
研究组 & 干预措施
C
all genotypes, non-responders or relapses
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
A
genotype 1, treatment-naive
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
A
genotype 1, treatment-naive
干预措施: ribavirin [Copegus] (Drug)
B
genotype 2 and 3, treatment-naive
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
B
genotype 2 and 3, treatment-naive
干预措施: ribavirin [Copegus] (Drug)
C
all genotypes, non-responders or relapses
干预措施: ribavirin [Copegus] (Drug)
结局指标
主要结局
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
时间窗: up to 96 weeks
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
时间窗: up to 96 weeks
次要结局
- Virological response/sustained virological response (serum HCV RNA levels)(24 weeks after treatment completion)