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 |
---|---|
Conditions: | Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/21/2016 |
Start Date: | April 2014 |
End Date: | March 2015 |
An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection
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.
ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
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.
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