Back to Trials
Accepting PatientsPhase 3 (Comparison)NCT06051617
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
Phase:Phase 3 (Comparison)
Status:Accepting Patients
Age:18+
Gender:All
Locations:218 sites
What This Study Is About
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Technical Description
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.
Who Can Participate
You May Qualify If
- 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 primary biliary cholangitis (PBC)
- Evidence of cirrhosis
- CP Score A or B
- +2 more...
You Cannot Join If
- 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.
- Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
- +9 more...
Discuss With Your Doctor
- Decompensated cirrhosis
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
- Platelet count ≤50×10\^3/µL
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2
- CP-C cirrhosis
Key Requirements
- Age 18+ years
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)
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
Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.
Study Locations
University of Alabama at Birmingham — Birmingham, Alabama
St. Joseph's Hospital and Medical Center - 350 W. Thomas — Phoenix, Arizona
OM Research LLC — Lancaster, California
Show all 218 locations
SCPMG/Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
Cedar Sinai Medical Center — Los Angeles, California
California Liver Research Institute — Pasadena, California
Stanford University — Redwood City, California
Kaiser Roseville — Roseville, California
University of California, Davis Medical Center — Sacramento, California
California Pacific Medical Center - Sutter Pacific Medical Foundation — San Francisco, California
Connie Frank Transplant Center at UCSF — San Francisco, California
Kaiser Permanente - South San Francisco Medical Center — South San Francisco, California
Covenant Metabolic Specialists, LLC — Fort Myers, Florida
Schiff Center for Liver Diseases/University of Miami — Miami, Florida
Covenant Metabolic Specialists, LLC — Sarasota, Florida
Florida Research Institute — Tampa, Florida
Piedmont Atlanta Hospital / Piedmont Transplant Institute — Atlanta, Georgia
Northwestern University — Chicago, Illinois
University of Chicago Medical Center — Chicago, Illinois
University Of Iowa Hospitals And Clinics — Iowa City, Iowa
University of Louisville, Clinical Trials Unit — Louisville, Kentucky
Ochsner Clinic Foundation — Jefferson, Louisiana
University Health System - East Jefferson General Hospital Campus — New Orleans, Louisiana
Mercy Medical Center — Baltimore, Maryland
Walter Reed National Military — Bethesda, Maryland
Massachusetts General Hospital — Boston, Massachusetts
Beth Israel Deaconess Medical Center — Boston, Massachusetts
Henry Ford Medical Center - Columbus — Detroit, Michigan
University of Rochester Medical Center - Strong Memorial Hospital — Rochester, Minnesota
Mayo Clinic — Rochester, Minnesota
Northwell Health Center for Liver Disease and Transplantation — Manhasset, New York
NYU Langone Health — New York, New York
New York-Presbyterian/Weill Cornell Medical Center — New York, New York
Mount Sinai — New York, New York
Wake Forest Baptist Medical Center — Winston-Salem, North Carolina
University Hosptials Cleveland Medical Center — Cleveland, Ohio
The Cleveland Clinic Foundation — Cleveland, Ohio
The Ohio State University Medical Center — Columbus, Ohio
The Oregon Clinic Gastroenterology East — Portland, Oregon
Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania
University of Pennsylvania Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania
Thomas Jefferson University — Philadelphia, Pennsylvania
UPMC Center for Liver Diseases — Pittsburgh, Pennsylvania
Medical University of South Carolina — Charleston, South Carolina
Gastro One — Cordova, Tennessee
The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas
University of Texas Southwestern Medical Center, Professional Office Building One — Dallas, Texas
Soma Clinical Trials — Denison, Texas
American Research Corporation — San Antonio, Texas
Pinnacle Clinical Research, PLLC — San Antonio, Texas
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax — Fairfax, Virginia
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads — Newport News, Virginia
VCU Health Clinical Research Services Unit (CRSU) — Richmond, Virginia
Liver Institute Northwest — Seattle, Washington
Medical College of Wisconsin - 8701 Watertown Plan — Milwaukee, Wisconsin
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
Hospital Provincial Del Centenario — Rosario
AES - AS - Clinica Mayo de Urgencias — San Miguel de Tucumán
Princess Alexandra Hospital — Queensland, Queensland
Flinders Medical Center — Adelaide, South Australia
Monash Health, Monash Medical Centre — Clayton, Victoria
Northern Health — Epping, Victoria
Alfred Hospital — Melbourne, Victoria
Landeskrankenhaus Hall — Hall in Tirol
Krankenhaus der Barmherzigen Brüder — Vienna
Medizinische Universität Wien — Vienna
Klinikum Wels-Grieskirchen GmbH - Standort Wels — Wels
UZ Antwerpen — Edegem
UZ Gent — Ghent
UZ Leuven - PPDS — Leuven
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
Centro de Investigación y Prevención Cardiovascular — La Serena
Pontificia Universidad Católica de Chile — Santiago
BIOCINETIC Ltda — Santiago
Clinical Research Chile SpA - PPDS — Valdivia
Beijing Youan Hospital, Capital Medical University — Beijing
Beijing Ditan Hospital, Capital Medical University — Beijing
Beijing Friendship Hospital, Capital Medical University — Beijing
The First Hospital of Jilin University — Changchun
West China Hospital of Sichuan University — Chengdu
The Second Affiliated Hospital of Chongqing Medical University — Chongqing
Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou
The Third Affiliated Hospital, Sun Yat-Sen University — Guangzhou
Guizhou Provincial People's Hospital — Guiyang
The First Affiliated Hospital of Anhui Medical University — Hefei
The First People's Hospital of Yunnan Province — Kunming
The Second Hospital of Nanjing — Nanjing
Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai
The First Affiliated Hospital of Xinjiang Medical University — Ürümqi
Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
The First Affiliated Hospital of PLA Air Force Medical University — Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
The First Affiliated Hospital, Zhejiang University School of Medicine — Zhejiang
Henan Provincial People's Hospital — Zhengzhou
The Third People's Hospital of Zhenjiang — Zhenjiang
Fakultni nemocnice Ostrava — Ostrava
RESEARCH Site s.r.o — Pilsen
Vseobecná fakultni nemocnice v Praze Nemocnicni lekarna odd. HVLP - Klinicke hodnoceni leciv — Prague
Aarhus Universitetshospital — Aarhus
AP-HP - Hopital Avicenne — Bobigny
Hôpital Claude Huriez-Lille-1 Place de Verdun — Lille
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse — Lyon
CHU-Montpellier-Hopital St Eloi — Montipellier
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris — Paris
AP-HP Hopital Henri Mondor — Paris
CHU de Strasbourg - Nouvel Hôpital Civil — Strasbourg
CHRU de Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy
AP-HP - Hôpital Paul Brousse — Villejuif
Universitätsklinikum Regensburg — Bayern
Charité Campus Virchow-Klinikum-Augustenburger Platz 1 — Berlin
Universitatsklinikum des Saarlandes — Homburg
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH — Kiel
Evangelismos General Hospital — Athens
University General Hospital of Larissa — Larissa
General Hospital of Thessaloniki ''Hippokratio'' — Thessaloniki
Prince of Wales Hospital - Hong Kong — Hong Kong
Queen Mary Hospital - PPDS — Hong Kong
Princess Margaret Hospital - Hong Kong — Hong Kong
Semmelweis Egyetem - Sebészeti, — Budapest
Somogy Varmegyei Kaposi Mor Oktato Korhaz — Kaposvár
Soroka University Medical Centre — Beersheba
Lady Davis Carmel Medical Center — Haifa
Liver Unit, institute of Gasteroenterology and Liver Diseases — Jerusalem
Rabin Medical Center - PPDS — Petah Tikva
Rambam Health Care Campus - PPDS — Ramat Gan
The Chaim Sheba Medical Center - PPDS — Ramat Gan
Tel Aviv Sourasky Medical Center Ichilov — Tel Aviv
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi — Ancona
IRCCS Saverio de Bellis-UOSD "Epatopatie" — Castellana Grotte
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico — Milan
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara — Modena
Fondazione IRCCS San Gerardo dei Tintori — Monza
Azienda Ospedale - Università Padova — Padova
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia — Palermo
A.O.U. Pisana, U.O. Epatologia — Pisa
Ospedale Casa Sollievo Della Sofferenza IRCCS — San Giovanni Rotondo
Clinica de Higado y Gastroenterologia Integral, S.C. — Cuernavaca
PROACTIVE CR MEXICO SA de CV — Irapuato
Consultorio Medico - Distrito Federal — Mexico City
Centro De Investigacion Y Gastroenterogia, S.C. — México
Oaxaca Site Management Organization - Hospital - OSMO - PPDS — Oaxaca City
FAICIC — Veracruz
ID Clinic Arkadiusz Pisula — Mysłowice
PlanetMed SP. z. o. o — Wroclaw
Centro Clínico Académico, Braga - Hospital de Braga — Braga
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães — Creixomil
Hospital da Luz Lisboa — Lisbon
ULS de Santo António, EPE - Hospital de Santo António — Porto
ULS de Matosinhos, EPE - Hospital Pedro Hispano — Porto
Galenus Group - Puerto Rico — Manati
Institutul Clinic Fundeni — Bucharest
National University Hospital — Singapore
Singapore General Hospital (SGH) — Singapore
Tan Tock Seng Hospital — Singapore
Changi General Hospital — Singapore
Pusan National University Hospital — Busan
Kyungpook National University Hospital — Daegu
Chonnam National University Hospital — Gwangju
Seoul National University Bundang Hospital — Seongnam
Asan Medical Center — Seoul
Korea University Guro Hospital — Seoul
Seoul National University Hospital — Seoul
Severance Hospital, Yonsei University Health System — Seoul
Samsung Medical Center — Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
Complexo Hospitalario Universitario De Santiago — A Coruña
Hospital Universitario Fundacion Alcorcon — Alcorcón
Hospital Universitario Germans Trias i Pujol — Badalona
Hospital del Mar — Barcelona
Hospital Universitario Vall d'Hebron-VIHR — Barcelona
Hospital Clinic de Barcelona — Barcelona
C.H. Regional Reina Sofia - PPDS — Córdoba
Hospital Universitario Virgen de la Victoria — Málaga
Hospital Universitario Marques de Valdecilla — Santander
Hospital Universitario Virgen del Rocio - PPDS — Seville
Universitätsspital Bern — Bern
Universitätsspital Zürich — Zurich
Chiayi Christian Hospital — Chiayi City
Kaohsiung Medical University Hospital — Kaohsiung City
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City
National Cheng Kung University Hospital — Tainan
National Taiwan University Hospital — Taipei
Taipei Veterans General Hospital — Taipei
Chang Gung Memorial Hospital, Linkou — Taoyuan
Adana City Training and Research Hospital — Adana
Ankara Bilkent City Hospital — Ankara
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital — Gaziantep
Uludag University Medical Faculty — Görükle
Ege University — Izmir
Katip Celebi University — Karabağlar
Kocaeli University Medical Faculty Hospital — Kocaeli
Mersin Universitesi Tip Fakultesi Hastanesi — Mersin
Marmara University Pendik Training and Research Hospital — Pendik
Rize Recep Tayyip Erdogan University Training and Research Hospital — Rize Merkez
Hull Royal Infirmary — Hull
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital — Ipswich
St James's University Hospital - PPDS — Leeds
The Royal London Hospital — London
Royal Free Hospital — London
King's College Hospital — London
Freeman Hospital — Newcastle upon Tyne
John Radcliffe Hospital — Oxford
Sheffield teaching hospital NHS foundation trust — Sheffield
New Cross Hospital — Wolverhampton
Contact
Experimental Treatment
This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.
Apply to This Trial
Your information will be sent to the study coordinator for review.