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)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic Hepatitis C
- 发起方
- Bristol-Myers Squibb International Corporation
- 入组人数
- 172
- 状态
- 进行中（未招募）
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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