ELfinity
Research type
Research Study
Full title
Prospective non-interventional, phase IV multicentre study to assess the effectiveness, safety and tolerability of elafibranor 80 mg/day in patients with primary biliary cholangitis receiving treatment in a real-world setting.
IRAS ID
343152
Contact name
Lynsey Corless
Contact email
Sponsor organisation
Ipsen Pharma SAS
Duration of Study in the UK
4 years, 3 months, 30 days
Research summary
This is an international, multi-centre, post-marketing, prospective study designed primarily to collect and assess real world data in adult patients with Primary Biliary Cholangitis (a type of liver disease that can gradually get worse over time) treated with elafibranor and secondly, to describe the safety and tolerability of treatment including its impact on the patients Quality of Life. Patients will receive elafibranor prescribed by their physician according to the SmPC/PI, the marketing authorization and as per usual local practice. All procedures in the study are standard of care (SoC) apart from the few questionnaires given to the patients and their caregivers to complete that are not very time-consuming.
Around 424 patients with PBC with an inadequate response or intolerance to Ursodeoxycholic Acid (UDCA) a first line therapy, will be enrolled. The decision to prescribe elafibranor will be made prior to and independently of the decision to enrol the patient in the study.
The duration of participation in the study is 24 months and the overall recruitment period for the study is expected to be approximately three years. The patients in the study can continue their treatment with elafibranor beyond 24‑months of the study period, however, no data will be collected after this period.
Following post marketing authorisation approval this study is expected is to be conducted at approximately 78 sites in Australia, Singapore, South Korea, Brazil, Austria, France, Germany, Greece, Italy, Spain, Switzerland, UAE, UK, USA and Canada. This study will not start in the UK until reimbursement is acquired.REC name
West of Scotland REC 1
REC reference
24/WS/0118
Date of REC Opinion
2 Oct 2024
REC opinion
Further Information Favourable Opinion