Overview

This trial is active, not recruiting.

Condition chronic hepatitis c virus (hcv) infection
Treatments abt-493/abt-530, placebo for abt-493/abt-530
Phase phase 3
Sponsor AbbVie
Start date November 2015
End date September 2016
Trial size 321 participants
Trial identifier NCT02640482, 2015-002348-14, M15-464

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
ABT-493/ABT-530 for 12 weeks
abt-493/abt-530
tablet
(Experimental)
Placebo for ABT-493/ABT-530 for 12 weeks followed by ABT-493/ABT-530 for 12 weeks
abt-493/abt-530
tablet
placebo for abt-493/abt-530
tablet

Primary Outcomes

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

Secondary Outcomes

Measure
Percentage of Participants in Arm A, excluding prior SOF + RBV ± pegIFN failures, with Virologic Failure During the Double-Blind Treatment Period
time frame: Up to Week 12
Percentage of Participants in Arm A, excluding prior SOF + RBV ± pegIFN failures, with Virologic Failure After the Double-Blind Treatment Period
time frame: Within 12 weeks after last dose of study drug
Percentage of Participants in Arm A with prior SOF + RBV ± pegIFN failure with Sustained Virologic Response 12 weeks After Treatment
time frame: 12 weeks after the 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-2 (GT2) infection. - Chronic HCV infection. - Subject must be HCV treatment-naïve or have failed previous HCV treatment. - Subject must be non-cirrhotic. Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. - Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. - Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. - Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). - HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype.

Additional Information

Official title A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.