EUCTR2010-022568-11-DE进行中（未招募）不适用
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 subjectsRevised Protocol Number: 02 Incorporates Administrative Letter 01, Amendment(s) 03 and 06 - The D-LITE Study: Direct Antiviral Agents plus Lambda Interferon Treatment Evaluation
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Chronic Hepatitis C, Genotype 1
- •HCV RNA >100,000 IU/mL at screening;
- •Seronegative for HIV and HBsAg;
- •Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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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