A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

• Status: Completed
• Trial end date: 2016-09-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

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

• Males must be surgically sterile or agree to practice acceptable forms of birth control

• Chronic hepatitis C virus (HCV) infection at screening

• Fibrosis stage F3 or greater, documented by acceptable tests

• Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)

• Use of contraindicated medications within 2 weeks of dosing

• Clinically significant abnormalities or co-morbidities

• History of solid organ transplant

• Abnormal laboratory tests

• Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation