A Prospective, Observational Cohort Study to Assess Long-Term Safety in Patients Prescribed Epidyolex® with a Focus on Drug-induced Liver Injury (DILI)

Study identification

• EU PAS number:
  EUPAS47466
• Study ID:
  50740
• Official title and acronym:
  A Prospective, Observational Cohort Study to Assess Long-Term Safety in Patients Prescribed Epidyolex® with a Focus on Drug-induced Liver Injury (DILI)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  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. PASS objectives include: • To assess DILI and its risk factors of Epidyolex in patients prescribed Epidyolex in standard clinical practice. • To assess the cognitive development/behaviour adverse drug reaction profile of Epidyolex in patients prescribed Epidyolex in standard clinical practice. • To further characterise the overall safety profile of Epidyolex patients in standard clinical practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 31/12/2021

Actual: 17/01/2022

Study start date

Planned: 17/03/2023

Actual: 26/05/2023

Date of final study report

Planned: 31/08/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GW Pharmaceuticals, part of Jazz Pharmaceuticals

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)