EUCTR2011-002793-23-GB进行中（未招募）不适用
A Phase 3 Evaluation of Daclatasvir (BMS-790052) in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects with Chronic Hepatitis C Genotype 4Revised Protocol Number 02; Incorporates amendment 04+ Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 12-Aug-11)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
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
- •Subjects chronically infected with HCV Genotype 4
- •HCV RNA viral load of = 10,000 IU/mL
- •No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent (DAA).
- •Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted.
- •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 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Evidence of decompensated liver disease
- •Documented or suspected HCC
- •Positive for HBsAg or HIV-1/HIV-2 antibody at screening
研究者
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