A 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 Infection

• Status: Completed
• Trial end date: 2017-02-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

• Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.

• Chronic HCV infection.

• Participant had to be either HCV treatment-naïve or treatment-experienced.

• Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any drug.

• Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.

• 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.

• Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).

• HCV genotype performed during screening indicating co-infection with more than one HCV genotype.