EUCTR2010-022867-37-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled trial of the efficacy and safety of DEB025/Alisporivir in combination with standard of care in hepatitis C genotype 1 treatment-naïve - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,040
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
- •-Chronic hepatitis C viral
- •-HCV genotype
- •-no previous treatment for hepatitis C infection
- •-Serum HCV RNA level = 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit.
- •-liver evaluation prior to Baseline: liver biopsy within 3 years or Fibroscan within 6 months.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria are :
- •-HCV genotype different from genotype 1 or co-infection with other HCV genotype.
- •-co-infection with Hepatitis B or HIV
- •-Any other cause of relevant liver disease other than HCV
- •-Presence or history of hepatic decompensation
- •-ALT = 10 times ULN,
- •- more than 1 episode of elevated bilirubin (>ULN) in past 6 months
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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