M16-135, Glecaprevir/Pibrentasvir in HCV GTs 1,2,4,5,6 with Cirrhosis
Research type
Research Study
Full title
A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
IRAS ID
226419
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-004967-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 17 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. For patients with cirrhosis, treating HCV can reduce the risk of liver disease and complications in the future.
Until recently, with the emergence of ‘Direct-Acting Antiviral Agents’ (DAAs), treatment options for HCV have been limited. DAAs work by targeting the different stages of the virus lifecycle and are generally well-tolerated.
AbbVie is currently developing two "next generation" DAAs, Glecaprevir (GLE) and Pibrentasvir (PIB). This study will test the drugs in combination to check that they are safe and effective for patients with HCV. Subjects who have HCV and Cirrhosis who have never had treatment for HCV could be eligible to take part in this study. Subjects will need to be in the early stages of cirrhosis and not have progressed to late stages of cirrhosis, known as decompensated cirrhosis.
Approximately 270 subjects will be included across approximately 135 sites worldwide. The study will be conducted in five hospitals in the UK. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 32 weeks. Subjects will receive study medication for 8 weeks then follow up for 24 weeks. The effect of the treatments on the virus will be checked by performing blood tests and collecting general medical health information. Safety and efficacy evaluations will occur throughout the study.
REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0355
Date of REC Opinion
17 Jul 2017
REC opinion
Further Information Favourable Opinion