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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Gilead Sciences · Participants: 402 · Started: Sep 7, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06051617

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArizonaSt. Joseph's Hospital and Medical Center - 350 W. Thomas, Phoenix
CaliforniaOM Research LLC, Lancaster
Cedar Sinai Medical Center, Los Angeles
SCPMG/Kaiser Permanente Los Angeles Medical Center, Los Angeles
California Liver Research Institute, Pasadena
Stanford University, Redwood City
University of California, Davis Medical Center, Sacramento
California Pacific Medical Center - Sutter Pacific Medical Foundation, San Francisco
Connie Frank Transplant Center at UCSF, San Francisco
Kaiser Permanente - South San Francisco Medical Center, South San Francisco
FloridaCovenant Metabolic Specialists, LLC, Fort Myers
Schiff Center for Liver Diseases/University of Miami, Miami
Covenant Metabolic Specialists, LLC, Sarasota
Florida Research Institute, Tampa
GeorgiaPiedmont Atlanta Hospital / Piedmont Transplant Institute, Atlanta
IllinoisNorthwestern University, Chicago
University of Chicago Medical Center, Chicago
IowaUniversity Of Iowa Hospitals And Clinics, Iowa City
KentuckyUniversity of Louisville, Clinical Trials Unit, Louisville
LouisianaOchsner Clinic Foundation, Jefferson
University Health System - East Jefferson General Hospital Campus, New Orleans
MarylandMercy Medical Center, Baltimore
Walter Reed National Military, Bethesda
MassachusettsBeth Israel Deaconess Medical Center, Boston
Massachusetts General Hospital, Boston
MichiganHenry Ford Medical Center - Columbus, Detroit
MinnesotaMayo Clinic, Rochester
University of Rochester Medical Center - Strong Memorial Hospital, Rochester
New YorkNorthwell Health Center for Liver Disease and Transplantation, Manhasset
Mount Sinai, New York
NYU Langone Health, New York
New York-Presbyterian/Weill Cornell Medical Center, New York
North CarolinaWake Forest Baptist Medical Center, Winston-Salem
OhioThe Cleveland Clinic Foundation, Cleveland
University Hosptials Cleveland Medical Center, Cleveland
The Ohio State University Medical Center, Columbus
PennsylvaniaPenn State Health Milton S. Hershey Medical Center, Hershey
Thomas Jefferson University, Philadelphia
University of Pennsylvania Perelman Center for Advanced Medicine, Philadelphia
UPMC Center for Liver Diseases, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TennesseeGastro One, Cordova
TexasThe Liver Institute at Methodist Dallas Medical Center, Dallas
University of Texas Southwestern Medical Center, Professional Office Building One, Dallas
Soma Clinical Trials, Denison
American Research Corporation, San Antonio
Pinnacle Clinical Research, PLLC, San Antonio
VirginiaMedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax, Fairfax
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads, Newport News
VCU Health Clinical Research Services Unit (CRSU), Richmond
WashingtonLiver Institute Northwest, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.