Overview

This trial is active, not recruiting.

Conditions hepatitis c virus infection, chronic hepatitis c, compensated cirrhosis
Treatment abt-493/abt-530
Phase phase 3
Sponsor AbbVie
Start date December 2015
End date October 2016
Trial size 175 participants
Trial identifier NCT02642432, 2015-003797-32, M14-172

Summary

The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-493/ABT-530 for 12 weeks
abt-493/abt-530
Tablet

Primary Outcomes

Measure
Percentage of Participants with Sustained Virologic Response 12 weeks After Treatment
time frame: 12 weeks after the last dose of study drug

Secondary Outcomes

Measure
Percentage of Participants with Virologic Failure During Treatment
time frame: Up to Week 12
Percentage of Participants with Virologic Failure After Treatment
time frame: Within 12 weeks after last dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 infection - Chronic HCV infection - Subject must be HCV treatment-naïve or have failed prior HCV treatment - Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease Exclusion Criteria: - Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus antibody - HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype - Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530

Additional Information

Official title A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.