Overview

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

Status:
Completed
Trial end date:
2014-08-01
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 1b (HCV GT1b) infection without cirrhosis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
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 1b-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