A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

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

• Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)

• Subject has never received antiviral treatment for hepatitis C infection

• 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 or anti-human immunodeficiency virus antibody

• Positive screen for drugs or alcohol

• Significant sensitivity to any drug

• Use of contraindicated medications within 2 weeks of dosing

• Abnormal laboratory tests