M13-583 (Endurance-4), ABT-493/ABT-530 in Hep C genotypes 4,5 and 6
Research type
Research Study
Full title
M13-583 A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
IRAS ID
186921
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2015-002349-80
Duration of Study in the UK
1 years, 2 months, 0 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 Hepatis C virus lifecycle. DAAs provide an alternative option to injectable therapies for patients with HCV and are generally well tolerated. Combinations of first generation DAAs which are approved as medicines to treat HCV have shown cure rates from HCV infection in excess of 90% with treatment durations of 12 or 24 weeks.
HCV exists in six major forms called HCV genotypes 1-6 and first generation DAA medicines do not treat all 6 HCV genotypes. The proportion of infections with a particular HCV genotype varies by geographic region. AbbVie’s Next Generation DAAs ABT-493 and ABT-530 to be used in this study are expected to be effective against all 6 major HCV genotypes.
This study will test the safety and effectiveness of a 12 week treatment course with the combination of ABT-493 and ABT-530 against HCV genotypes 4, 5 or 6 infection in persons without cirrhosis of the liver and who have not previously been treated with DAAs.
Approximately 120 subjects will be included from approximately 30 sites in 7 participating countries. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 41 weeks including a screening period of up to 35 days. 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
North West - Haydock Research Ethics Committee
REC reference
15/NW/0700
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion