Study Details

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Primary Biliary Cholangitis

Gender

N/A

Date

September 2023 - August 2030

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Seladelpar, Placebo

Eligibility Information

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 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) ≥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

Locations

Locations (52)

OM Research LLC

Lancaster, California, United States, 93534

SCPMG/Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

California Liver Research Institute

Pasadena, California, United States, 91105

University of California, Davis Medical Center

Sacramento, California, United States, 95817

California Pacific Medical Center - Sutter Pacific Medical Foundation

San Francisco, California, United States, 94115

Connie Frank Transplant Center at UCSF

San Francisco, California, United States, 94143

Covenant Metabolic Specialists, LLC

Fort Myers, Florida, United States, 33606

Florida Research Institute

Lakewood Ranch, Florida, United States, 34211

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States, 33136

Covenant Metabolic Specialists, LLC

Sarasota, Florida, United States, 33912

Piedmont Atlanta Hospital / Piedmont Transplant Institute

Atlanta, Georgia, United States, 30309

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States, 52242

University of Louisville, Clinical Trials Unit

Louisville, Kentucky, United States, 40202

Ochsner Clinic Foundation

Jefferson, Louisiana, United States, 70121

University Health System - East Jefferson General Hospital Campus

New Orleans, Louisiana, United States, 70112

Mercy Medical Center

Baltimore, Maryland, United States, 21202

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Henry Ford Medical Center - Columbus

Detroit, Michigan, United States, 48202

MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax

Plymouth, Minnesota, United States, 55446

Northwell Health Center for Liver Disease and Transplantation

Manhasset, New York, United States, 11030

NYU Langone Health

New York, New York, United States, 10016

Mount Sinai

New York, New York, United States, 10029

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

University Hosptials Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

UPMC Center for Liver Diseases

Pittsburgh, Pennsylvania, United States, 15213

Gastro One

Cordova, Tennessee, United States, 38018

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States, 75203

University of Texas Southwestern Medical Center, Professional Office Building One

Dallas, Texas, United States, 75390

Pinnacle Clinical Research, PLLC

San Antonio, Texas, United States, 78229

Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads

Newport News, Virginia, United States, 23602

VCU Health Clinical Research Services Unit (CRSU)

Richmond, Virginia, United States, 23249

Liver Institute Northwest

Seattle, Washington, United States, 98105

Flinders Medical Center

Adelaide, South Australia, Australia, 5042

Alfred Hospital

Melbourne, Victoria, Australia, 3004

Pusan National University Hospital

Busan, Korea, Republic of, 49241

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of, 13620

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 3722

Adana City Training and Research Hospital

Adana, Turkey, 1370

Ankara Bilkent City Hospital

Ankara, Turkey, 06800

Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital

Gaziantep, Turkey, 27630

Uludag University Medical Faculty

Gorukle, Turkey, 16059

Ege University

Izmir, Turkey, 35040

Katip Celebi University

Karabağlar, Turkey, 35150

Kocaeli University Medical Faculty Hospital

Kocaeli, Turkey, 41380

Rize Recep Tayyip Erdogan University Training and Research Hospital

Maltepe, Turkey, 34840

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, Turkey, 33169

Marmara University Pendik Training and Research Hospital

Pendik, Turkey, 34899

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (52)

OM Research LLC

SCPMG/Kaiser Permanente Los Angeles Medical Center

California Liver Research Institute

University of California, Davis Medical Center

California Pacific Medical Center - Sutter Pacific Medical Foundation

Connie Frank Transplant Center at UCSF

Covenant Metabolic Specialists, LLC

Florida Research Institute

Schiff Center for Liver Diseases/University of Miami

Covenant Metabolic Specialists, LLC

Piedmont Atlanta Hospital / Piedmont Transplant Institute

University of Chicago Medical Center

University Of Iowa Hospitals And Clinics

University of Louisville, Clinical Trials Unit

Ochsner Clinic Foundation

University Health System - East Jefferson General Hospital Campus

Mercy Medical Center

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Henry Ford Medical Center - Columbus

MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax

Northwell Health Center for Liver Disease and Transplantation

NYU Langone Health

Mount Sinai

Wake Forest Baptist Medical Center

University Hosptials Cleveland Medical Center

Penn State Health Milton S. Hershey Medical Center

Thomas Jefferson University

UPMC Center for Liver Diseases

Gastro One

The Liver Institute at Methodist Dallas Medical Center

University of Texas Southwestern Medical Center, Professional Office Building One

Pinnacle Clinical Research, PLLC

Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads

VCU Health Clinical Research Services Unit (CRSU)

Liver Institute Northwest

Flinders Medical Center

Alfred Hospital

Pusan National University Hospital

Kyungpook National University Hospital

Seoul National University Bundang Hospital

Severance Hospital, Yonsei University Health System

Adana City Training and Research Hospital

Ankara Bilkent City Hospital

Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital

Uludag University Medical Faculty

Ege University

Katip Celebi University

Kocaeli University Medical Faculty Hospital

Rize Recep Tayyip Erdogan University Training and Research Hospital

Mersin Universitesi Tip Fakultesi Hastanesi

Marmara University Pendik Training and Research Hospital