NCT00292084已完成2 期
A Phase II, Multi-Center, Extension Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With or Without Ribavirin, for an Additional 36 Weeks
BioWest Therapeutics Inc1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety analysis
研究概览
简要总结
This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed HCV-05-002 only
- •18-65 years of age, inclusive
- •Primary diagnosis of chronic HCV infection
- •Non-responders to previous pegylated interferon-based therapy
排除标准
- •Patients naive to interferon-based therapy for chronic HCV infection
结局指标
主要结局
Safety analysis
HCV viral load reduction from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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