Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
ACTIVE NOT RECRUITINGN/A

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

Sponsor: Ipsen

NCT ID: NCT06447168

View on ClinicalTrials.gov ↗

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).

Primary Biliary Cholangitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * Participant has provided written informed consent 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 treatment with commercialized elafibranor. * If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected. Exclusion Criteria: * Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance. * Participant with known hypersensitivity to the product or to any of its excipients. * Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Where Is This Study? (9 UK sites)

Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

Aberdeen, United Kingdom

Hospital R&D contact (matched)

Fiona Brebner

gram.randd@nhs.scot01224 551121

Belfast Health and Social Care Trust - Royal Victoria Hospital

Belfast, United Kingdom

Hospital R&D contact (matched)

Alison Murphy

alison.murphy@belfasttrust.hscni.net028 9063 6366

Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

Bradford, United Kingdom

Hospital R&D contact (matched)

Jane Dennison

bradfordresearch.applications@bthft.nhs.uk01274 382575

Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

King's College Hospital NHS Foundation Trust

London, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

Newcastle, United Kingdom

Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Queen's Medical Centre - Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---
Data sourced from ClinicalTrials.gov · Last verified: 2026-09