NCT01679834已完成不适用
A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,500
- 主要终点
- Sustained virological response
研究概览
简要总结
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of chronic hepatitis C
- •Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label
排除标准
- •Contraindications against Pegasys or Copegus
- •Not willing or unable to sign written informed consent form
结局指标
主要结局
Sustained virological response
时间窗: 24 weeks after end of treatment
次要结局
- Rapid virological response(4 weeks after start of treatment)
- Early Virological Response(12 weeks after start of treatment)
- Safety: incidence of adverse events(up to 24 weeks after end of treatment)
研究者
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