Phase 3 study for people with Primary Biliary Cholangitis
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Princess Alexandra Hospital | Queensland | QLD | Recruiting |
| Flinders Medical Center | Adelaide | SA | Recruiting |
| Monash Health, Monash Medical Centre | Clayton | VIC | Recruiting |
| Northern Health | Epping | VIC | Recruiting |
| Alfred Hospital | Melbourne | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 13 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 6 October 2026.
- This page last checked by Voxsanity: 13 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.