Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Seladelpar, Placebo.
- Who it may be relevant to
- Registry conditions: Primary Biliary Cholangitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +23
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Detailed description
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Interventions
- Drug 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. - Drug Placebo
One capsule daily for up to 36 months.
Primary outcome measures
- Event Free Survival (EFS) [Time frame: 36 months]
Secondary outcome measures (4)
- Overall survival [Time frame: 36 months]
- Liver transplant-free survival [Time frame: 36 months]
- Time to hospitalization [Time frame: 36 months]
- Time to Event Free Survival (EFS) [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
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
- 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)
Exclusion criteria
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
- Evidence of portal vein thrombosis based on imaging at time of Screening 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, 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
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 51 centers
- University of Alabama at Birmingham — Birmingham
- St. Joseph's Hospital and Medical Center - 350 W. Thomas — Phoenix
- OM Research LLC — Lancaster
- SCPMG/Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Cedar Sinai Medical Center — Los Angeles
- California Liver Research Institute — Pasadena
- Stanford University — Redwood City
- University of California, Davis Medical Center — Sacramento
- … and 43 more centers
China · 20 centers
Center list to be confirmed — check the primary protocol.
Italy · 10 centers
Center list to be confirmed — check the primary protocol.
South Korea · 10 centers
Center list to be confirmed — check the primary protocol.
Spain · 10 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 10 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 10 centers
Center list to be confirmed — check the primary protocol.
Argentina · 9 centers
- Hospital Italiano de Buenos Aires — Buenos Aires
- Consultorios Médicos Dr. Doreski - PPDS — Buenos Aires
- Buenos Aires Mácula — Buenos Aires
- Centro de Investigación y Prevención Cardiovascular — Buenos Aires
- AES - AS - Glenny Corp. S.A. Buenos Aires — Buenos Aires
- Higea S.A. — Mendoza
- DIM Clinica Privada — Ramos Mejía
- CINME S.A. - Centro de Investigaciones Metabólicas — Recoleta
- … and 1 more center
France · 8 centers
Center list to be confirmed — check the primary protocol.
Canada · 7 centers
- University of Calgary — Calgary
- University of Alberta — Edmonton
- Centre Hospitalier de l'Universite de Montreal — Montreal
- Ottawa Hospital — Ottawa
- Diex Recherche - Québec - PPDS — Québec
- Toronto General Hospital — Toronto
- GI Research Institute Foundation — Vancouver
Israel · 7 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 7 centers
Center list to be confirmed — check the primary protocol.
Mexico · 6 centers
Center list to be confirmed — check the primary protocol.
Australia · 5 centers
- Princess Alexandra Hospital — Queensland
- Flinders Medical Center — Adelaide
- Monash Health, Monash Medical Centre — Clayton
- Northern Health — Epping
- Alfred Hospital — Melbourne
Austria · 4 centers
- Landeskrankenhaus Hall — Hall in Tirol
- Krankenhaus der Barmherzigen Brüder — Vienna
- Medizinische Universität Wien — Vienna
- Klinikum Wels-Grieskirchen GmbH - Standort Wels — Wels
Chile · 4 centers
- Centro de Investigación y Prevención Cardiovascular — La Serena
- … and 3 more centers
Singapore · 4 centers
Center list to be confirmed — check the primary protocol.
Belgium · 3 centers
- UZ Antwerpen — Edegem
- UZ Gent — Ghent
- UZ Leuven - PPDS — Leuven
Germany · 3 centers
Center list to be confirmed — check the primary protocol.
Greece · 3 centers
Center list to be confirmed — check the primary protocol.
Hong Kong · 3 centers
Center list to be confirmed — check the primary protocol.
Czechia · 2 centers
Center list to be confirmed — check the primary protocol.
Hungary · 2 centers
Center list to be confirmed — check the primary protocol.
Poland · 2 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 2 centers
Center list to be confirmed — check the primary protocol.
Denmark · 1 center
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Romania · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06051617 · CB8025-41837 · 2024-516525-31-00