At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 93 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- Not specified
- Who
- All
- Number of participants
- 424
- Started
- 2024-10-14
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for primary biliary cholangitis
- • Clinical study - 424 participants
- • This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting
Who can take part?
- • Adults
- • Diagnosed with primary biliary cholangitis
Where?
- • Aberdeen - Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
- • Belfast - Belfast Health and Social Care Trust - Royal Victoria Hospital
- • Birmingham - Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • Bradford - Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
What the study is looking for
- ✓Participant has provided written agreement to take part and agrees to comply with the study protocol.
- ✓Participant with PBC diagnosis.
- ✓Participant for whom the treating physician has decided to start or participants who are currently receiving...
- ✓If a participant has a caregiver who agrees to complete the caregiver questionnaires, an agreement to take part should be...
Who cannot take part
- ✗Participant is currently participating or, plans to participate in an investigational drug study or medical device...
- ✗Participant with known hypersensitivity to the product or to any of its excipients.
- ✗Participant with mental instability or incompetence, such that the validity of agreement to take part or ability to be...
See the full criteria
Where Is This Study? (9 UK sites)
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen, United Kingdom
Belfast Health and Social Care Trust - Royal Victoria Hospital
Belfast, United Kingdom
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, United Kingdom
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903King's College Hospital NHS Foundation Trust
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle, United Kingdom
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
