A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults with Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection.

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 80 人开始时间: 2016年12月19日最近更新: 2018年9月24日

研究概览

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•1. Male or female, at least 18 years of age at time of Screening.
•2. Screening laboratory result indicating HCV GT5 or 6 infection.
•3. Subject has a positive anti-HCV Ab and plasma HCV RNA = 1000 IU/mL at Screening Visit.
•4. Subject must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed = 2 months prior to screening.
•5. Subject must be documented as having no cirrhosis or compensated cirrhosis (as described in Section 5.3.1.1) non-cirrhotic or cirrhotic.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
•2. Female subject who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
•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.

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