A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Antiviral Agents; Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.

• Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.

• Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.

• Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

Exclusion Criteria:

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

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).

• Prior therapy for the treatment of HCV.

• Any current or past clinical evidence of cirrhosis.

• Any cause of liver disease other than chronic HCV-infection.

• HCV genotype co-infection with any other HCV genotype.

• Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.