M13-590 - HCV Genotype 1 - treatment naive (ENDURANCE-1)
Research type
Research Study
Full title
M13-590: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 1 Infection
IRAS ID
185674
Contact name
Daniel Forton
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2015-002087-17
Duration of Study in the UK
1 years, 2 months, 7 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.
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.
This study will test the safety and effectiveness of two new DAAs (ABT-493 with ABT-530) for up to 12 weeks of treatment, in genotype 1 HCV infected adults without cirrhosis, who are either treatment-naïve (received no previous treatment for their HCV) or received prior treatment with interferons (with or without Ribavirin).
Approximately 600 subjects will be included across approximately 100 sites worldwide. The study has two arms, each enrolling approximately 300 patients.
Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 41 weeks, including the screening period. Subjects will receive study medication for either 8 or 12 weeks then follow up for 24 weeks. Safety and efficacy evaluations will occur throughout the study.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0699
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion