Testing Seladelpar against a placebo for primary biliary cholangitis
Official title: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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
- Phase 3
- 2 groups
- Sites in Calgary, Edmonton and 5 more cities
- Recruiting
Interventions
- Medication
Seladelpar
* Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or * Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.
- Medication
Placebo
One capsule daily for up to 36 months.
Canadian Sites (7)
7 of 7 recruiting
- Recruiting
University of Calgary
Calgary
- Recruiting
University of Alberta
Edmonton
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal
- Recruiting
Ottawa Hospital
Ottawa
- Recruiting
Diex Recherche - Québec - PPDS
Québec
- Recruiting
Toronto General Hospital
Toronto
- Recruiting
GI Research Institute Foundation
Vancouver
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 PBC
- +Evidence of cirrhosis
- +CP Score A or B
- +Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
- +Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth controlControl groupThe group a new treatment is measured against.Read more → 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
Exclusion
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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
- −Evidence of portal vein thrombosis based on imaging at time of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → by Doppler ultrasound or prior evidence by CT or MRI
- −Hospitalization for liver-related complication within 12 weeks of Screening
- −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, baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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
- −CP-C cirrhosis
- −History or presence of other concomitant liver diseases
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Seladelpar.
Registry label: A: Seladelpar
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 318 people.
The study is currently expected to finish around August 2030.
The main measurement is taken over: 36 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Event Free Survival (EFS) — measured over 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06051617 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SeladelparDrug
* Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or * Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
One capsule daily for up to 36 months.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 36 months.
The study as a whole is currently expected to finish around 2030-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 318 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Calgary, Canada; Edmonton, Canada; Montreal, Canada; Ottawa, Canada; Québec, Canada; Toronto, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Other Sites (8)
Henry Ford Medical Center - Columbus
Detroit, Michigan, United States
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Liver Institute Northwest
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.