M16-123: Glecaprevir/Pibrentasvir in HCV Infected Paediatric Patients
Research type
Research Study
Full title
M16-123: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects with Genotypes 1 – 6 Chronic Hepatitis C Virus (HCV) Infection
IRAS ID
226448
Contact name
Deirdre Kelly
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2016-004102-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 1 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.
Children represent only a small proportion of the HCV-infected population. Nevertheless, a substantial number of children have chronic HCV infection and are at risk for complications. In the past, these patients were not often treated for their HCV infection as the medicines available included interferon, which was 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.
This study will test the safety and effectiveness of glecaprevir/pibrentasvir in paediatric HCV subjects. Treatment length (8, 12, or 16 weeks) with glecaprevir/pibrentasvir will be dependent on the patient’s genotype, cirrhosis status and whether or not the patient was previous treated for HCV infection.
Approximately 100 subjects will be included across approximately 40 sites worldwide. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study could last up to approximately 166 weeks. Subjects will receive study medication for either 8, 12 or 16 weeks and then be followed up for 144 weeks (3 years). Safety and efficacy evaluations will occur throughout the study.REC name
Scotland B REC
REC reference
17/SS/0110
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion