EUCTR2013-002468-20-FR
进行中（未招募）
1 期
A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects with Genotype 1 Chronic Hepatitis C
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- HEPATITIS C VIRUS
- 发起方
- Bristol-Myers Squibb International Corporation
- 入组人数
- 472
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Key Inclusion Criteria:
- •Subjects chronically infected with HCV genotype 1
- •HCV RNA \= 10,000 IU/mL at screening;
- •Treatment\-naïve subjects with no previous exposure to an interferon formulation (ie, IFNa, pegIFNa), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
- •Treatment\-experienced subjects are eligible including previous exposure to anti\-HCV agents of a mechanistic class other than those contained in the DCV/ASV/BMS\-791325 triple regimen
- •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 414
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •Key Exclusion Criteria:
- •Evidence of cirrhosis
- •Liver or any other organ transplant
- •Current or known history of cancer within 5 years prior to screening
- •Documented or suspected HCC,
- •Evidence of decompensated liver
结局指标
主要结局
未指定
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