NCT00332176Unknown2 期
A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C
BioWest Therapeutics Inc3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Safety analysis
研究概览
简要总结
The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •18-65 years of age, inclusive
- •primary diagnosis of chronic HCV infection, genotype 1
- •Interferon-based treatment-naïve
- •Body Mass Index of 18 to 30, inclusive
排除标准
- •patients previously treated with Interferon-based therapy
- •patients with diabetes mellitus
研究组 & 干预措施
1
Experimental
干预措施: Celgosivir (Drug)
2
Experimental
干预措施: Celgosivir (Drug)
3
Active Comparator
干预措施: Peginterferon alfa 2b + ribavirin (Drug)
结局指标
主要结局
Safety analysis
时间窗: 12 weeks
HCV viral load
时间窗: 12 weeks
Pharmacokinetics of celgosivir/castanospermine
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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