ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

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

Details

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

Criteria

Inclusion Criteria:

• Males and females 18-70 years old, inclusive

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control

• Chronic hepatitis C virus (HCV), genotype 1 infection

• Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)

• No evidence of liver cirrhosis

Exclusion Criteria:

• Significant liver disease with any cause other than HCV as the primary cause

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

• Positive screen for drugs and alcohol

• Significant sensitivity to any drug

• Use of contraindicated or prohibited medications within 1 month of dosing

• Abnormal laboratory tests