Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, hepatitis c virus
Treatments abt-450/r, abt-530, ribavirin (rbv)
Phase phase 2
Sponsor AbbVie
Start date June 2013
End date January 2015
Trial size 20 participants
Trial identifier NCT02068222, M14-213

Summary

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-450/r and ABT-530 co-administered with ribavirin (RBV) for 12 weeks
abt-450/r
Tablet
abt-530
Tablet
ribavirin (rbv)
Tablet
(Experimental)
ABT-450/r and ABT-530 co-administered for 12 weeks
abt-450/r
Tablet
abt-530
Tablet

Primary Outcomes

Measure
The percentage of subjects who achieve 12-week sustained virologic response (SVR12) in each treatment arm
time frame: 12 weeks after last dose of study drug

Secondary Outcomes

Measure
The percentage of subjects who achieve 24-week sustained virologic response (SVR24) in each treatment arm
time frame: 24 weeks after last dose of study drug
The percentage of subjects with virologic failure during treatment
time frame: Up to Treatment Week 12
The percentage of subjects with Post-Treatment relapse
time frame: Within 12 weeks after the last dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2. - Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV. - Subject has plasma HCV RNA level > 10,000 IU/mL at Screening. - Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug. Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any drug. - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab). - Prior therapy for the treatment of HCV. - Any current or past clinical evidence of cirrhosis. - Any cause of liver disease other than chronic HCV-infection. - HCV genotype co-infection with any other HCV genotype. - Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Additional Information

Official title An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by AbbVie.