EUCTR2012-003534-17-GB进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
入选标准
- •Treatment naïve,treatment experienced patients to an approved PegIFN/RBV regimen (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response) and treatment experienced to interferon 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 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
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
- •Patients who have been previously treated with an investigational or approved DAA.
研究者
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BI 207127 / faldaprevir combination therapy in hepatic impairment (Child-Pugh B) patients with genotype 1b chronic hepatitis C infectioChronic Hepatitis C InfectionEUCTR2012-003534-17-DEBoehringer Ingelheim Pharma GmbH & Co. KG35
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