Tests seladelpar in people with primary biliary cholangitis and compensated cirrhosis
Tests seladelpar against placebo in adults with liver disease and cirrhosis.
Key facts
- Who runs it
- Gilead Sciences
- Where
- Ancona, Castellana Grotte, Milan, Modena, Monza, Padova, Palermo, Pisa, and San Giovanni Rotondo, ItalySee the 10 sitesAlso in 28 other countries, 210 sites
- Trial code
- NCT06051617
- EU 2024-516525-31-01
- 2024-516525-31-00
- Registry title
- Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 402 people, planned
- Started
- 7 Sept 2023
- Expected to end
- Aug 2030
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Seladelpar
- Placebo
- Record updated
- 2 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis (PBC) and compensated cirrhosis who have not taken seladelpar before.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed primary biliary cholangitis with evidence of cirrhosis, Child-Pugh (CP) score A or B. Decompensated cirrhosis and CP-C cirrhosis are not allowed.
- Earlier treatment
- No earlier treatment with seladelpar. No history of liver transplant and not listed for a transplant.
- Biomarker or test result
- Blood test limits at screening are required, for example alkaline phosphatase (ALP) at least 1.5× and below 10× the upper limit of normal, MELD score 12 or lower, and INR 1.7 or lower.
Main reasons for not taking part
- Earlier exposure to seladelpar
- Decompensated cirrhosis or CP-C cirrhosis
- History of liver transplant or listed for a transplant
- Blood clot in the portal vein
- Other liver diseases at the same time
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
- 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
- Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
Who cannot take part
- Prior exposure to seladelpar
- Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
- History or presence of other concomitant liver diseases
- 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
- Laboratory parameters at Screening:; Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN; Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN; Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN; Platelet count ≤50×10\^3/µL; Albumin ≤2.8 g/dL; Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m\^2; 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; Serum alpha-fetoprotein (AFP) >20 ng/mL; INR >1.7
- Individuals must not meet any of the following criteria to be eligible for study participation:
- Decompensated cirrhosis
- Hospitalization for liver-related complication within 12 weeks of Screening
- CP-C cirrhosis
Where in Italy
Also in 28 other countries, 210 sites
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- National Institute of Gastroenterology Saverio De Bellis Research HospitalCastellana Grotte, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- SeladelparTreatment being tested
Participants with Child-Pugh (CP)-A cirrhosis will receive seladelpar 10 mg orally once daily or participants with CP-B cirrhosis will receive seladelpar 5 mg orally once daily, for up to 36 months.
- PlaceboPlacebo, for comparison
Participants with CP-A or CP-B will be randomized to received placebo to match one capsule daily for up to 36 months.
- Open Label Extension PhaseTreatment being tested
Participants with CP-A who remained on the study drug at week 156 will receive seladelpar 10 mg daily or participants with CP-B will received seladelpar 5 mg daily for a maximum of 3 years.
Treatment: Seladelpar
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
- Plain-language title
- Tests seladelpar in people with primary biliary cholangitis and compensated cirrhosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 November 2026