JPRN-jRCT2080221455未知2 期
A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects
Bristol-Myers K.K.0 个研究点目标入组 189 人开始时间: 2011年5月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 189
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: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Chronic Hepatitis C, Genotype 1
- •HCV RNA >100,000 IU/mL at screening;
- •Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
- •Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
排除标准
- •Any evidence of liver disease other than HCV;
- •Co-infection with HIV;
- •Diagnosed or suspected hepatocellular carcinoma;
- •Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin
研究者
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