Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
- Registration Number
- NCT06051617
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 318
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)
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) ≥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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seladelpar Seladelpar - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Event Free Survival (EFS) 36 months EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events:
1. Death by any cause;
2. Liver transplantation;
3. MELD score ≥15;
4. Ascites requiring treatment;
5. Hospitalization for any of the following:
1. Esophageal or gastric variceal bleeding
2. Hepatic encephalopathy
3. Spontaneous bacterial peritonitis
- Secondary Outcome Measures
Name Time Method Time to Event Free Survival (EFS) 36 months 1. MELD score ≥15
2. Ascites requiring treatmentOverall survival 36 months Time from start of treatment to death from any cause.
Liver transplant-free survival 36 months Time from start of treatment to the first occurrence of liver-related death or liver transplantation.
Time to hospitalization 36 months Time from start of treatment to the first occurrence of hospitalization for qualifying PBC clinical events
Trial Locations
- Locations (106)
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
🇹🇷Gaziantep, Turkey
SCPMG/Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation
🇺🇸San Francisco, California, United States
Connie Frank Transplant Center at UCSF
🇺🇸San Francisco, California, United States
Covenant Metabolic Specialists, LLC
🇺🇸Sarasota, Florida, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Schiff Center for Liver Diseases/University of Miami
🇺🇸Miami, Florida, United States
Piedmont Atlanta Hospital / Piedmont Transplant Institute
🇺🇸Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
🇺🇸Iowa City, Iowa, United States
University of Louisville, Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
University Health System - East Jefferson General Hospital Campus
🇺🇸New Orleans, Louisiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Gastro One
🇺🇸Germantown, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Medical Center - Columbus
🇺🇸Detroit, Michigan, United States
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
🇺🇸Plymouth, 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
Mount Sinai
🇺🇸New York, New York, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University Hosptials Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
OM Research LLC
🇺🇸Lancaster, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center, Professional Office Building One
🇺🇸Dallas, Texas, United States
Pinnacle Clinical Research, PLLC
🇺🇸San Antonio, Texas, United States
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
🇺🇸Richmond, Virginia, United States
VCU Health Clinical Research Services Unit (CRSU)
🇺🇸Richmond, Virginia, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Adana City Training and Research Hospital
🇹🇷Adana, Turkey
Ege University
🇹🇷Bornova, Turkey
Ankara Bilkent City Hospital
🇹🇷Cankaya, Turkey
Uludag University Medical Faculty
🇹🇷Gorukle, Turkey
Katip Celebi University
🇹🇷Karabağlar, Turkey
Kocaeli University Medical Faculty Hospital
🇹🇷Kocaeli, Turkey
Rize Recep Tayyip Erdogan University Training and Research Hospital
🇹🇷Maltepe, Turkey
Mersin Universitesi Tip Fakultesi Hastanesi
🇹🇷Mersin, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Pendik, Turkey
OM Research LLC
🇺🇸Lancaster, California, United States
SCPMG/Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedar Sinai Medical Center
🇺🇸Los Angeles, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation
🇺🇸San Francisco, California, United States
Connie Frank Transplant Center at UCSF
🇺🇸San Francisco, California, United States
Covenant Metabolic Specialists, LLC
🇺🇸Sarasota, Florida, United States
Schiff Center for Liver Diseases/University of Miami
🇺🇸Miami, Florida, United States
Florida Research Institute
🇺🇸Tampa, Florida, United States
Piedmont Atlanta Hospital / Piedmont Transplant Institute
🇺🇸Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
🇺🇸Iowa City, Iowa, United States
University of Louisville, Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸Jefferson, Louisiana, United States
University Health System - East Jefferson General Hospital Campus
🇺🇸New Orleans, Louisiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Medical Center - Columbus
🇺🇸Detroit, Michigan, United States
Northwell Health Center for Liver Disease and Transplantation
🇺🇸Manhasset, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University Hosptials Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
Gastro One
🇺🇸Cordova, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center, Professional Office Building One
🇺🇸Dallas, Texas, United States
Pinnacle Clinical Research, PLLC
🇺🇸San Antonio, Texas, United States
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
🇺🇸Fairfax, Virginia, United States
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
🇺🇸Newport News, Virginia, United States
VCU Health Clinical Research Services Unit (CRSU)
🇺🇸Richmond, Virginia, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
Buenos Aires Mácula
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro de Investigación y Prevención Cardiovascular
🇨🇱La Serena, Chile
Flinders Medical Center
🇦🇺Adelaide, South Australia, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
GI Research Institute Foundation
🇨🇦Vancouver, Canada
Pontificia Universidad Católica de Chile
🇨🇱Santiago, Chile
BIOCINETIC Ltda
🇨🇱Santiago, Chile
Clinical Research Chile SpA - PPDS
🇨🇱Valdivia, Chile
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Adana City Training and Research Hospital
🇹🇷Adana, Turkey
Ankara Bilkent City Hospital
🇹🇷Ankara, Turkey
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
🇹🇷Gaziantep, Turkey
Uludag University Medical Faculty
🇹🇷Gorukle, Turkey
Ege University
🇹🇷Izmir, Turkey
Katip Celebi University
🇹🇷Karabağlar, Turkey
Kocaeli University Medical Faculty Hospital
🇹🇷Kocaeli, Turkey
Mersin Universitesi Tip Fakultesi Hastanesi
🇹🇷Mersin, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Pendik, Turkey
Rize Recep Tayyip Erdogan University Training and Research Hospital
🇹🇷Rize Merkez, Turkey