EUCTR2015-002012-33-ES进行中（未招募）1 期
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •1. Chronic HCV infection.
- •2. Screening laboratory result indicating either HCV genotype 1a or genotype 4 infection.
- •3. Subject has never received antiviral treatment for hepatitis C infection.
- •4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method
- •5. No evidence of liver cirrhosis.
- •6. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Women who are pregnant or breastfeeding.
- •2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-Human immunodeficiency virus antibody (HIV Ab)
- •3. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the subject an unsuitable candidate for this study or to receive ombitasvir/paritaprevir/ritonavir or dasabuvir.
- •4. Any prior antiviral therapy for HCV, including investigational or commercially approved agents.
- •5. Any current or past clinical evidence of cirrhosis.
研究者
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