A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV)

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

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

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Chronic hepatitis C virus (HCV)

• Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin

• Males and females 18-65 years old

• Body mass index 18 to < 35 kg/m^2

• Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion Criteria:

• Cirrhosis or extensive bridging fibrosis

• History of cardiac disease

• Positive screen for certain drugs or alcohol

• Abnormal laboratory results

• Significant sensitivity to any drug

• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

• Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing