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.
- Conditions
- Chronic hepatitis C virus genotype 5 or 6 infection, cirrhosisMedDRA version: 20.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000074171Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-003192-22-BE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy by evaluating the percentage of subjects achieving a 12-week post-treatment sustained virologic failure response (SVR12) in combined treatment arms and safety of treatment with the Glecaprevir/Pibrentasvir combination regimen in adults with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection with and without cirrhosis.;Secondary Objective: To assess the percentage of subjects with HCV on-treatment virologic failure, and the percentage of subjects with HCV virologic relapse in combined treatment arms.;Primary end point(s): SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) within each genotype (GT5 and GT6 subjects) separately across treatment arms.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The percentage of subjects with on-treatment HCV virologic failure and the percentage of subjects with post-treatment HCV virologic relapse within each genotype (GT5 and GT6 subjects) separately, across treatment arms.;Timepoint(s) of evaluation of this end point: 1) During treatment and at the end of treatment with at least 6 weeks of treatment. 2) At the end of treatment and 12 weeks after last dose of treatment.