Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, hepatitis c virus, genotype 3 hepatitis c virus
Treatments abt-493/abt-530, sofosbuvir, daclatasvir
Phase phase 3
Sponsor AbbVie
Start date December 2015
End date December 2016
Trial size 460 participants
Trial identifier NCT02640157, 2015-002272-24, M13-594

Summary

The purpose of this study is to compare the safety and efficacy of ABT-493/ABT-530 to the combination of Sofosbuvir (SOF) and Daclatasvir (DCV) in adults with genotype 3 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 open label
Primary purpose treatment
Arm
(Experimental)
ABT-493/ABT-530 QD for 12 weeks
abt-493/abt-530
(Active Comparator)
SOF 400 mg QD + DCV 60 mg QD for 12 weeks
sofosbuvir Sovaldi
sofosbuvir 400 mg tablets
daclatasvir Daklinza
daclatasvir 30 mg tablets
daclatasvir Daklinza
daclatasvir 60 mg tablets
(Experimental)
ABT-493/ABT-530 QD for 8 weeks
abt-493/abt-530

Primary Outcomes

Measure
Percentage of Participants With Sustained Virologic Response 12 weeks After Treatment (SVR12): Non-inferiority Analysis
time frame: 12 weeks after last dose of study drug

Secondary Outcomes

Measure
Percentage of Participants With Sustained Virologic Response 12 weeks After Treatment (SVR12): Superiority Analysis
time frame: 12 weeks after last dose of study drug
Percentage of Participants With Virologic Failure During Treatment
time frame: 8 or 12 weeks
Percentage of Participants With Post-treatment Relapse
time frame: Within 12 weeks post treatment

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: - Screening laboratory result indicating HCV GT3 infection - Chronic HCV infection - Subject must be treatment-naïve - Subjects must be non-cirrhotic Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any excipients 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 co-infection with more than one HCV genotype.

Additional Information

Official title A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered With Daclatasvir in Adults With Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.