M15-462 (EXPEDITION-4) GT 1 - 6 Chronic HCV with Renal Impairment
Research type
Research Study
Full title
Clinical Study Protocol M15-462: A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-4)
IRAS ID
190741
Contact name
Ashley Brown
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2015-002353-35
Duration of Study in the UK
0 years, 11 months, 16 days
Research summary
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This can lead to scarring of the liver (cirrhosis) and liver cancer: patients may then need a liver transplant.
The presence of HCV is common among those with end stage renal disease (when the kidneys permanently fail to work). In the past, these patients were not often treated for their HCV infection as medicines available include interferon and ribavirin, which when combined together were not as well-tolerated or as effective as the newer drugs in development.
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. Currently there are no approved HCV DAA treatments for use in HCV-infected persons with severe renal impairment.
This study will test the safety and effectiveness of the study drugs for 12 weeks of treatment, in adults who have chronic HCV infection and chronic renal impairment (e.g. stage 4 or 5 chronic kidney disease), who may or may not have compensated cirrhosis, and who may be either treatment-naïve (received no previous treatment for their HCV) or have received prior treatment. If treatment extension criteria are met, subjects may receive an additional 4 weeks of study drug.
Approximately 100 subjects will be included across approximately 20 sites worldwide.
Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 41-45 weeks, including the screening period. Subjects will receive study medication for 12-16 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/0871
Date of REC Opinion
23 Nov 2015
REC opinion
Further Information Favourable Opinion