EUCTR2015-003797-32-ES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 Adults with Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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 HCV GT1, 2, 4, 5, or 6 infection.
- •3. Chronic HCV infection.
- •4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy. Prior HCV treatment with any other approved or investigational medications is not allowed.
- •5. Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
- •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
研究者
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