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Looking for participantsPhase3

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Sponsor: Gilead Sciences

NCT ID: NCT06051617

View on ClinicalTrials.gov ↗

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.

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: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFRAFP

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
Inclusion Criteria: Individuals must meet the following criteria to be eligible for study participation: 1. Must be at least 18 years old. 2. Must have a confirmed prior diagnosis of primary biliary cholangitis (PBC) 3. Evidence of cirrhosis 4. CP Score A or B 5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose 6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA) Exclusion Criteria: Individuals must not meet any of the following criteria to be eligible for study participation: 1. Prior exposure to seladelpar 2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study 3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant. 4. Decompensated cirrhosis 5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI 6. Hospitalization for liver-related complication within 12 weeks of Screening 7. Laboratory parameters at Screening: 1. Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN 2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN 3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN 4. Platelet count ≤50×10\^3/µL 5. Albumin ≤2.8 g/dL 6. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2 7. MELD score \>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor. 8. Serum alpha-fetoprotein (AFP) \>20 ng/mL 9. INR \>1.7 8. CP-C cirrhosis 9. History or presence of other concomitant liver diseases

Where Is This Study? (10 UK sites)

Hull Royal Infirmary

Hull HU32JZ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

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

East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital

Ipswich IP4 5PD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Frances Farnworth

R&D@esneft.nhs.uk01473 704787

St James's University Hospital - PPDS

Leeds LS9 7TF, United Kingdom

Recruiting

The Royal London Hospital

London E1 1BB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Royal Free Hospital

London NW2 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting

Sheffield teaching hospital NHS foundation trust

Sheffield S10 2JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

How to Get in Touch

Gilead Clinical Study Information Center

Sponsor contact

CONTACT

1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10