NCT00475072已完成4 期
An Open Label Study to Evaluate the Safety and Effect on Sustained Virological Response of PEGASYS Plus Ribavirin in Patients With Hemophilia A and Chronic Hepatitis C
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- SVR
研究概览
简要总结
This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients, >=18 years of age;
- •hemophilia A;
- •chronic hepatitis C;
- •compensated liver disease.
排除标准
- •therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months before start of study drug;
- •hepatitis A, hepatitis B or HIV infection;
- •chronic liver disease other than chronic hepatitis C.
研究组 & 干预措施
1
Experimental
干预措施: ribavirin (Drug)
1
Experimental
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
SVR
时间窗: Week 72
次要结局
- AEs, laboratory parameters.(Throughout study)
研究者
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