Overview

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV)

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Ribavirin
Ritonavir
Criteria
Inclusion Criteria:

- Chronic hepatitis C virus (HCV)

- Treatment naive, null or partial responders to previous treatment with peginterferon
and ribavirin

- Males and females 18-65 years old

- Body mass index 18 to < 35 kg/m^2

- Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion Criteria:

- Cirrhosis or extensive bridging fibrosis

- History of cardiac disease

- Positive screen for certain drugs or alcohol

- Abnormal laboratory results

- Significant sensitivity to any drug

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

- Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic
anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1
month of dosing