A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

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

Details

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

Criteria

Inclusion Criteria:

• Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.

• Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.

• Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).

• No evidence of liver cirrhosis.

Exclusion Criteria:

• Positive screen for drugs or alcohol.

• Significant sensitivity to any drug.

• Use of contraindicated medications within 2 weeks of dosing.

• Certain predefined abnormal laboratory tests.

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