A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

• Status: Completed
• Trial end date: 2021-05-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate Long-term outcomes following treatment with ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

1. Males and females at least 18 years old at screening

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

3. Chronic hepatitis C, genotype 1 infection

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

5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing

2. Abnormal laboratory tests

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

4. Confirmed presence of hepatocellular carcinoma

5. History of solid organ transplant