EUCTR2013-002458-66-FR进行中（未招募）1 期
A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Subjects with Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Key Inclusion Criteria:
- •Subjects chronically infected with HCV genotype 1
- •Subjects with compensated cirrhosis;
- •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 exposure to anti-HCV agents of a mechanistic class other than those contained in the DCV/ASV/BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of NS5B polymerase, inhibitors of cyclophilin, or inhibitors of
- •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 282
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 43
排除标准
- •Key Exclusion Criteria:
- •Subjects without 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 disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
研究者
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