NCT00227435已完成1 期
A Phase I/II Double-Blind, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Val-mCyd (NM283) in Adults With Chronic Hepatitis C
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.
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
- Double
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
- •Documented clinical history of chronic hepatitis C and compensated liver disease
- •No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breastfeeding
- •Patient is co-infected with HBV or HIV
- •Other protocol-defined exclusion criteria may apply.
研究者
研究点 (4)
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