A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
Time Frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment
Time Frame: 4 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment
Percentage of Participants With Post-treatment Relapse
Time Frame: From the end of treatment through 12 weeks after the last dose of study drug
Interventions:
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-493
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
- Drug: ABT-530
Enrollment:
174
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
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