M13-594 - Study in Subjects with Genotype 3 Chronic HCV infection
Research type
Research Study
Full 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)
IRAS ID
184469
Contact name
David Mutimer
Contact email
Sponsor organisation
AbbVie
Eudract number
2015-002272-24
Duration of Study in the UK
1 years, 1 months, 15 days
Research summary
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer, and patients may then need a liver transplant.
Treatment options for HCV infection are limited for patients. Drug companies are developing drugs called ‘Direct Acting Antiviral Agents’ (DAAs) which work by targeting the different stages of the virus lifecycle. DAAs provide an alternative option to injectable therapies for patients with HCV and are generally well tolerated.
One DAA which has been approved for use is sofosbuvir (SOF). The combination of SOF and daclatasvir (DCV) has shown sustained virological response rates in previously untreated HCV genotype 3 (GT3) infected patients (without cirrhosis) of 97.6%, with 12 weeks of treatment.
This study will test the safety and effectiveness of ABT-493 and ABT-530 over a 12 week treatment course compared to SOF and DCV over 12 weeks, in HCV GT3 DAA treatment-naïve (those who have received no previous DAA treatment for their HCV) subjects without cirrhosis.
Approximately 345 subjects will be included across approximately 75 sites worldwide. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 36 weeks. Subjects will receive study medication for 12 weeks then follow up for 24 weeks. Safety and efficacy evaluations will occur throughout the study.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0487
Date of REC Opinion
30 Nov 2015
REC opinion
Further Information Favourable Opinion