M16-133 Glecaprevir/Pibrentasvir therapy in Patients with APRI ≤ 1
Research type
Research Study
Full title
A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir(GLE)/Pibrentasvir(PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1 – 6 Infection and Aspartate aminotransferase to Platelet Ratio Index (APRI) ≤ 1
IRAS ID
226413
Contact name
Stephen Thomas Barclay
Contact email
Sponsor organisation
AbbVie
Eudract number
2016-004876-23
Duration of Study in the UK
0 years, 10 months, 30 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. HCV exists in six major forms called HCV genotypes 1-6.
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 Hepatitis C. Subjects who have Hepatitis C and have never had treatment could be eligible to take part in this study. Subjects will need to have an aminotransferase/platelet ratio index (APRI, a blood test result) of 1 or less (which is predictive of non-cirrhosis) to be able to take part in the trial.
Approximately 230 subjects will be included across approximately 43 sites worldwide. The study will be conducted in four 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 24 weeks. Subjects will receive study medication for 8 weeks then will be followed up for 12 weeks. The effect of the treatment 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
West of Scotland REC 1
REC reference
17/WS/0165
Date of REC Opinion
13 Sep 2017
REC opinion
Further Information Favourable Opinion