Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 with and without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infectio
- Conditions
- Chronic Hepatitis C Virus (HCV) InfectionMedDRA version: 18.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002927-90-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 725
1. Male or female at least 18 years of age at time of screening.
2. Screening laboratory result indication HCV GT2, GT3, GT4, GT5, or GT6 infection.
3. Chronic HCV infection.
4. Subject must be either HCV treatment-naïve or treatment-experienced.
5. Subject must be documented as non-cirrhotic or to have compensated cirrhosis (GT3 only).
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 660
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
1. History of severe, life-threatening or other significant sensitivity to any 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.
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 and safety of ABT-493 and ABR-530 (or ABT-493/ABT-530) with or without RBV in subjects with chronic HCV genotype 2, 3, 4, 5 or 6 infection. In Part 4, the primary objectives include to assess the efficacy (SVR12) of treatment with the ABT-493/ABT-530 combination regimen in GT2-infected DAA-naïve subjects without cirrhosis compared to a historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected DAA-naïve subjects without<br>cirrhosis.;Secondary Objective: To assess the pharmacokinetics of ABT-493, ABT-530, and RBV and the emergence and persistence of viral variants with these treatment regimens;Primary end point(s): The percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) in each treatment arm.;Timepoint(s) of evaluation of this end point: Post-Treatment Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? The percentage of subjects with SVR4 (HCV RNA < LLOQ 4 weeks after the last actual dose of study drug);<br>? The percentage of subjects with on treatment virologic failure;<br>? The percentage of subjects with post-treatment relapse.;Timepoint(s) of evaluation of this end point: Treatment Period, Post-Treatment Period, Post-Treatment Week 4