NCT02640157

A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was 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 (GT3) chronic hepatitis C virus (HCV) infection.

Detailed description

This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Conditions

• Chronic Hepatitis C
• Hepatitis C Virus
• Genotype 3 Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	ABT-493/ABT-530	Tablet; ABT-493 coformulated with ABT-530
DRUG	Sofosbuvir	Tablet
DRUG	Daclatasvir	Tablet

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-10-01
• Completion: 2017-02-01
• First posted: 2015-12-28
• Last updated: 2021-07-30
• Results posted: 2017-09-15

Regulatory

• FDA-regulated drug study