EUCTR2011-004237-14-GB进行中（未招募）1 期
A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Revised Protocol 02 incorporating protocol amendment 03 (version 1.0 dated 22-Jan-13). + Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 23-Nov-11) + Administrative Letter 01 Site Specific dated 27-Mar-2012 - COMMAND-3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 793
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
入选标准
- •- Subjects chronically infected with HCV genotype 1a or 1b
- •-HCV RNA viral load =10,000 IU/mL
- •- No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals
- •- if no prior history of cirrhosis
- •liver biopsy within 3 years or Fibroscan® within 1 year
- •-Body Mass Index (BMI) of 18 to 35 kg/m2
- •-Negative for HIV and Hepatitis B
- •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 810
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- Evidence of decompensated liver disease
- •- Evidence of medical condition contributing to chronic liver disease other than HCV
研究者
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