EUCTR2012-003534-17-DE进行中（未招募）不适用
A phase IIb open-label study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- •Treatment-naïve patients, or treatment-experienced to an approved PegIFN/RBV regimen (prior relapse, interferon intolerant, and prior partial response), or treatment-experienced to IFN not as part of an approved PegIFN/RBV regimen.
- •Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
- •Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening.
- •Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
- •HIV infection.
- •Previous treatment with an investigational or approved direct acting antiviral drug (DAA).
- •Patients classified as Child Pugh C (score 10-15 points).
研究者
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