M15-942 DAA Re-Treatment for Virologic Failures in AbbVie HCV Studies
Research type
Research Study
Full title
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies(MAGELLAN-3).
IRAS ID
217921
Contact name
Ashley Brown
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2016-002491-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 26 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 ABT-493/ABT-530 in combination with sofosbuvir and ribavirin over a 12 or 16 week treatment course, in subjects who have already participated in an AbbVie HCV trial and who still have the virus. Subjects must have been previously treated with an AbbVie drug combination.
Approximately 40 subjects will be included globally. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 46 weeks. Subjects will receive study medication for 12 or 16 weeks then follow up for 24 weeks. Safety and efficacy evaluations will occur throughout the study.REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/0401
Date of REC Opinion
17 Mar 2017
REC opinion
Favourable Opinion