JPRN-jRCT2080221958未知3 期
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects with a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers
Bristol-Myers K.K.0 个研究点目标入组 224 人开始时间: 2012年11月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •chronic HCV-1b infected patient
- •- HCV RNA > 100,000 IU/mL at screening
- •- ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort),
- •- Treatment naive subjects to IFN based therapy
- •- Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up.
排除标准
- •Patients who have;
- •- hepatocellular carcinoma
- •- co-infection with HBV or HIV
- •- severe or uncontrollable complication
研究者
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