Phase
Condition
Liver Disorders
Liver Disease
Primary Biliary Cholangitis
Treatment
Seladelpar 10 mg
Placebo
Seladelpar
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 asecond effective birth control method during the study and for at least 90 daysafter the last dose. Male individuals who are sexually active with female partnersof reproductive potential must use barrier contraception, and their female partnersmust 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 drugadministration and be able to complete the study schedule of assessments (SOA)
Exclusion
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, wouldpreclude full participation in the study
History of liver transplantation or actively listed for cadaveric or planned livingdonor transplant.
Decompensated cirrhosis
Evidence of portal vein thrombosis based on imaging at time of Screening by Dopplerultrasound 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) ≥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, baselineInternational normalized ratio (INR) determination for MELD score calculationshould take anticoagulant use into account, in consultation with the MedicalMonitor.
Serum alpha-fetoprotein (AFP) >20 ng/mL
INR >1.7
CP-C cirrhosis
History or presence of other concomitant liver diseases
Study Design
Study Description
Connect with a study center
Flinders Medical Center
Adelaide, South Australia 5042
AustraliaActive - Recruiting
Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
GI Research Institute Foundation
Vancouver, V6G 2Z6
CanadaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
Pusan National University Hospital
Busan, 49241
Korea, Republic ofActive - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
Korea, Republic ofActive - Recruiting
Adana City Hospital
Yüreğir, Adana 1370
TurkeySite Not Available
Katip Celebi University
İzmir, Karabaglar 35150
TurkeySite Not Available
Adana City Training and Research Hospital
Adana, 1370
TurkeyActive - Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
TurkeyActive - Recruiting
Ege University
Bornova, 35100
TurkeySite Not Available
Uludag University Medical Faculty Gorkule Kampusu
Bursa, 16059
TurkeySite Not Available
Ankara Bilkent City Hospital
Cankaya, 06800
TurkeySite Not Available
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
Gaziantep, 27630
TurkeyActive - Recruiting
Uludag University Medical Faculty
Gorukle, 16059
TurkeyActive - Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
TurkeySite Not Available
Ege University
Izmir, 35040
TurkeyActive - Recruiting
Katip Celebi University
Karabağlar, 35150
TurkeyActive - Recruiting
Kocaeli University Medical Faculty Hospital
Kocaeli, 41380
TurkeyActive - Recruiting
Rize Recep Tayyip Erdogan University Training and Research Hospital
Maltepe, 34840
TurkeySite Not Available
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33110
TurkeyActive - Recruiting
Marmara University Pendik Training and Research Hospital
Pendik, 34899
TurkeyActive - Recruiting
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53020
TurkeySite Not Available
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, 53020
TurkeyActive - Recruiting
Ege University, Department of Gastroenterology
İzmir, 35100
TurkeyActive - Recruiting
OM Research LLC
Lancaster, California 93534
United StatesActive - Recruiting
Cedar Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
SCPMG/ Kaise Permanente Los Angeles Medical Center
Los Angeles, California 90027
United StatesActive - Recruiting
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United StatesActive - Recruiting
California Liver Research Center
Pasadena, California 91105
United StatesActive - Recruiting
California Liver Research Institute
Pasadena, California 91105
United StatesActive - Recruiting
University of California, Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
University of California, Davis Medical Center (Study Visits)
Sacramento, California 95817
United StatesActive - Recruiting
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California 94109
United StatesActive - Recruiting
Connie Frank Transplant Center at UCSF
San Francisco, California 94143
United StatesActive - Recruiting
Covenant Metabolic Specialists, LLC
Fort Myers, Florida 33912
United StatesActive - Recruiting
Florida Research Institute
Lakewood Ranch, Florida 34211
United StatesSite Not Available
Florida Research Institute, LLC
Lakewood Ranch, Florida 34211
United StatesActive - Recruiting
Schiff Center for Liver Diseases/University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
University of Miami Hospital
Miami, Florida 33136
United StatesActive - Recruiting
Covenant Metabolic Specialists, LLC
Sarasota, Florida 33912
United StatesActive - Recruiting
Florida Research Institute
Tampa, Florida 34211
United StatesActive - Recruiting
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia 30309
United StatesActive - Recruiting
Piedmont Atlanta Hospital/Piedmont Transplant Institute
Atlanta, Georgia 30309
United StatesActive - Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
University Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Louisville, Clinical Trials Unit
Louisville, Kentucky 40202
United StatesActive - Recruiting
Ochsner Clinic Foundation
Jefferson, Louisiana 70121
United StatesActive - Recruiting
University Healthcare System East Jefferson General Hospital Campus
Metairie, Louisiana 70006
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesActive - Recruiting
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Mercy Medical Center
Baltimore, Maryland 21202
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Beth Israel Deconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Henry Ford Medical Center - Columbus
Detroit, Michigan 48202
United StatesActive - Recruiting
Henry Ford Medical Center
Novi, Michigan 48377
United StatesSite Not Available
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Plymouth, Minnesota 55446
United StatesSite Not Available
Ochsner Clinic Foundation
Jefferson City, Missouri 70121
United StatesSite Not Available
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York 11030
United StatesActive - Recruiting
Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hosptials Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Gastro One
Cordova, Tennessee 38018
United StatesActive - Recruiting
Gastro One
Germantown, Tennessee 38138
United StatesSite Not Available
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas 75203
United StatesActive - Recruiting
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas 75390
United StatesActive - Recruiting
Pinnacle Clinical Research, LLC
San Antonio, Texas 78229
United StatesActive - Recruiting
Pinnacle Clinical Research, PLLC
San Antonio, Texas 78229
United StatesActive - Recruiting
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Fairfax, Virginia 22031
United StatesActive - Recruiting
Medstar Health Research Institute/MedStar Georgetown Transplant
Fairfax, Virginia 22031
United StatesSite Not Available
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia 23602
United StatesActive - Recruiting
Mayview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia 23602
United StatesSite Not Available
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Richmond, Virginia 23226
United StatesSite Not Available
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia 23298
United StatesActive - Recruiting
Liver Institute Northwest
Seattle, Washington 98105
United StatesActive - Recruiting
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