EUCTR2015-002353-35-BE进行中（未招募）1 期
A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-4)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Male or female at least 18 years of age at time of Screening.
- •2. Screening laboratory result indicating chronic HCV GT1-6 infection.
- •3. Subject must be HCV treatment-naïve or have received prior HCV treatment with IFN or pegIFN with or without RBV, pegIFN/RBV plus SOF, or SOF plus RBV.
- •4. Subject must have chronic renal impairment (CKD stage 4 or 5).
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
- •2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
- •3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- •4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- •5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
研究者
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