An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 主要终点
- Percentage of Participants With at Least 1 Adverse Event
研究概览
简要总结
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.
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.
- •Chronic hepatitis C.
- •Compensated liver disease (Child-Pugh Class A).
- •Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
- •Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
- •Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
- •For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
- •Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
排除标准
- •Pregnant or breastfeeding women.
- •Male partners of women who are pregnant.
- •Patients with hemoglobinopathies.
- •Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
- •Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
- •Liver disease other than chronic hepatitis C, including hepatic carcinoma.
研究组 & 干预措施
Peginterferon alfa-2a monotherapy or combined with ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
干预措施: Peginterferon alfa-2a (Drug)
Peginterferon alfa-2a monotherapy or combined with ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With at Least 1 Adverse Event
时间窗: From Baseline to the end of the study (up to 72 weeks)
次要结局
未报告次要终点