Long term safety in patients prescribed Epidyolex V1
Research type
Research Study
Full title
A Prospective, Observational Cohort Study to Assess Long-Term Safety in Patients Prescribed Epidyolex® with a Focus on Drug-induced Liver Injury (DILI)
IRAS ID
320369
Contact name
Anita Devlin
Contact email
Sponsor organisation
GW Pharma (International) B.V.
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
This is a multicentre, prospective, non-interventional observational cohort study of patients who are planned to receive, or already receiving Epidyolex under real-world conditions of clinical care. This study is designed to address a Pharmacovigilance Risk Assessment Committee (PRAC) request to conduct a Category 3 Post-Authorisation Safety Study (PASS), as requested in the Risk Management Plan (RMP) at the time of approval. While 12 safety concerns were noted in the RMP, PRAC emphasis was on the need to further characterize the important identified risk of hepatocellular injury (one phenotype of Drug-induced liver injury (DILI)), and the safety concerns particularly related to Epidyolex® consequences on neurological development (“impact on cognitive development and behavior”), when used under conditions of usual routine clinical care.
REC name
London - Bromley Research Ethics Committee
REC reference
23/PR/0498
Date of REC Opinion
18 Dec 2023
REC opinion
Further Information Favourable Opinion