JPRN-jRCT2080222495未知3 期
A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 286
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Males and females, at least 20 years of age
- •Subjects chronically infected with HCV GT-1
- •HCV RNA viral load of not less than 100,000 IU/m
排除标准
- •Hepatocellular carcinoma
- •Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
- •Severe or uncontrollable complication
研究者
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进行中（未招募）
不适用
PH III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Inelgibles. Naives)HEPATITIS C VIRUSMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005446-35-DEBristol-Myers Squibb International Corporation1,100