At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Seladelpar (drug), Placebo (drug)
- How long the study runs
- Study runs about 83 months (dates as stated)
- About the drug or intervention
- Seladelpar — drug: Administered orally · Placebo — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 402
- Started
- 2023-09-07
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for primary biliary cholangitis
- • Phase3 - 402 participants
- • The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with primary biliary cholangitis
Where?
- • Hull - Hull Royal Infirmary
- • Ipswich - East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
- • Leeds - St James's University Hospital - PPDS
- • London - The Royal London Hospital
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis. The primary objective of this study is to evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156.
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: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a confirmed prior diagnosis of primary biliary cholangitis (PBC)
What the study is looking for
- ✓Individuals must meet the following criteria to be eligible for study participation:
- ✓Must be at least 18 years old.
- ✓Must have a confirmed prior diagnosis of primary biliary cholangitis (PBC)
- ✓Evidence of cirrhosis
- ✓CP Score A or B
Who cannot take part
- ✗Individuals must not meet any of the following criteria to be eligible for study participation:
- ✗Prior exposure to seladelpar
- ✗A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
- ✗History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
- ✗Decompensated cirrhosis
See the full criteria
Where Is This Study? (10 UK sites)
Hull Royal Infirmary
Hull HU32JZ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich IP4 5PD, United Kingdom
St James's University Hospital - PPDS
Leeds LS9 7TF, United Kingdom
The Royal London Hospital
London E1 1BB, United Kingdom
Royal Free Hospital
London NW2 2QG, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Sheffield teaching hospital NHS foundation trust
Sheffield S10 2JF, United Kingdom
New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
Gilead Clinical Study Information Center
Sponsor contactCONTACT
