Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis | NCT06051617 | Trialant

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis | NCT06051617 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 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)

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, 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) ≤ 0.6 × ULN or ≥ 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

University of Alabama at BirminghamRecruiting

Birmingham, Alabama 35233, United States

St. Joseph's Hospital and Medical Center - 350 W. ThomasRecruiting

Phoenix, Arizona 85013, United States

OM Research LLCRecruiting

Lancaster, California 93534, United States

SCPMG/Kaiser Permanente Los Angeles Medical CenterRecruiting

Los Angeles, California 90027, United States

Cedar Sinai Medical CenterRecruiting

Los Angeles, California 90048, United States

California Liver Research InstituteRecruiting

Pasadena, California 91105, United States

Stanford UniversityRecruiting

Redwood City, California 94063, United States

University of California, Davis Medical CenterRecruiting

Sacramento, California 95817, United States

California Pacific Medical Center - Sutter Pacific Medical FoundationRecruiting

San Francisco, California 94109, United States

Connie Frank Transplant Center at UCSFRecruiting

San Francisco, California 94143, United States

Kaiser Permanente - South San Francisco Medical CenterRecruiting

South San Francisco, California 94080, United States

Covenant Metabolic Specialists, LLCRecruiting

Fort Myers, Florida 33912, United States

Schiff Center for Liver Diseases/University of MiamiRecruiting

Miami, Florida 33136, United States

Covenant Metabolic Specialists, LLCRecruiting

Sarasota, Florida 33912, United States

Florida Research InstituteRecruiting

Tampa, Florida 34211, United States

Piedmont Atlanta Hospital / Piedmont Transplant InstituteRecruiting

Atlanta, Georgia 30309, United States

Northwestern UniversityRecruiting

Chicago, Illinois 60611, United States

University of Chicago Medical CenterRecruiting

Chicago, Illinois 60637, United States

University Of Iowa Hospitals And ClinicsRecruiting

Iowa City, Iowa 52242, United States

University of Louisville, Clinical Trials UnitRecruiting

Louisville, Kentucky 40202, United States

Ochsner Clinic FoundationRecruiting

Jefferson, Louisiana 70121, United States

University Health System - East Jefferson General Hospital CampusRecruiting

New Orleans, Louisiana 70112, United States

Mercy Medical CenterRecruiting

Baltimore, Maryland 21202, United States

Walter Reed National MilitaryRecruiting

Bethesda, Maryland 20889, United States

Massachusetts General HospitalRecruiting

Boston, Massachusetts 02114, United States

Beth Israel Deaconess Medical CenterRecruiting

Boston, Massachusetts 02215, United States

Henry Ford Medical Center - ColumbusRecruiting

Detroit, Michigan 48202, United States

University of Rochester Medical Center - Strong Memorial HospitalRecruiting

Rochester, Minnesota 14642, United States

Mayo ClinicRecruiting

Rochester, Minnesota 55905, United States

Northwell Health Center for Liver Disease and TransplantationRecruiting

Manhasset, New York 11030, United States

NYU Langone HealthRecruiting

New York, New York 10016, United States

New York-Presbyterian/Weill Cornell Medical CenterRecruiting

New York, New York 10021, United States

Mount SinaiRecruiting

New York, New York 10029, United States

Wake Forest Baptist Medical CenterRecruiting

Winston-Salem, North Carolina 27157, United States

University Hosptials Cleveland Medical CenterRecruiting

Cleveland, Ohio 44106, United States

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Cleveland, Ohio 44195, United States

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Columbus, Ohio 43210, United States

Penn State Health Milton S. Hershey Medical CenterRecruiting

Hershey, Pennsylvania 17033, United States

University of Pennsylvania Perelman Center for Advanced MedicineRecruiting

Philadelphia, Pennsylvania 19104, United States

Thomas Jefferson UniversityRecruiting

Philadelphia, Pennsylvania 19107, United States

UPMC Center for Liver DiseasesRecruiting

Pittsburgh, Pennsylvania 15213, United States

Medical University of South CarolinaRecruiting

Charleston, South Carolina 29425, United States

Gastro OneRecruiting

Cordova, Tennessee 38018, United States

The Liver Institute at Methodist Dallas Medical CenterRecruiting

Dallas, Texas 75203, United States

University of Texas Southwestern Medical Center, Professional Office Building OneRecruiting

Dallas, Texas 75390, United States

Soma Clinical TrialsRecruiting

Denison, Texas 75020, United States

American Research CorporationRecruiting

San Antonio, Texas 78215, United States

Pinnacle Clinical Research, PLLCRecruiting

San Antonio, Texas 78229, United States

MedStar Health Research Institute / MedStar Georgetown Transplant Institute at FairfaxRecruiting

Fairfax, Virginia 22031, United States

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

Newport News, Virginia 23602, United States

VCU Health Clinical Research Services Unit (CRSU)Recruiting

Richmond, Virginia 23298, United States

Liver Institute NorthwestRecruiting

Seattle, Washington 98105, United States

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Buenos Aires, 1181, Argentina

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Buenos Aires, 1426, Argentina

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Buenos Aires, C1061, Argentina

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Buenos Aires, C1061, Argentina

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Mendoza, M5500, Argentina

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Ramos Mejía, 1704, Argentina

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Rosario, 2000, Argentina

Princess Alexandra HospitalRecruiting

Queensland, Queensland 4102, Australia

Flinders Medical CenterRecruiting

Adelaide, South Australia 5042, Australia

Monash Health, Monash Medical CentreRecruiting

Clayton, Victoria 3168, Australia

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Epping, Victoria 3076, Australia

Alfred HospitalRecruiting

Melbourne, Victoria 3004, Australia

Landeskrankenhaus HallRecruiting

Hall in Tirol, 6060, Austria

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Vienna, 1020, Austria

Medizinische Universität WienRecruiting

Vienna, 1090, Austria

Klinikum Wels-Grieskirchen GmbH - Standort WelsRecruiting

Wels, 4600, Austria

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

University of CalgaryRecruiting

Calgary, T2N 4Z6, Canada

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Edmonton, T6G 2B7, Canada

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Montreal, H2L 4M1, Canada

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Ottawa, K1H 8L6, Canada

Diex Recherche - Québec - PPDSRecruiting

Québec, G1V 4T3, Canada

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Toronto, M5G 2C4, Canada

GI Research Institute FoundationRecruiting

Vancouver, V6G 2Z6, Canada

Centro de Investigación y Prevención CardiovascularRecruiting

La Serena, 1720506, Chile

Pontificia Universidad Católica de ChileRecruiting

Santiago, 8320000, Chile

BIOCINETIC LtdaRecruiting

Santiago, 8330336, Chile

Clinical Research Chile SpA - PPDSRecruiting

Valdivia, 5110683, Chile

Beijing Youan Hospital, Capital Medical UniversityRecruiting

Beijing, 100000, China

Beijing Ditan Hospital, Capital Medical UniversityRecruiting

Beijing, 100015, China

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Beijing, 100050, China

The First Hospital of Jilin UniversityRecruiting

Changchun, 130021, China

West China Hospital of Sichuan UniversityRecruiting

Chengdu, 610047, China

The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting

Chongqing, 401336, China

Mengchao Hepatobiliary Hospital of Fujian Medical UniversityRecruiting

Fuzhou, China

The Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting

Guangzhou, 510630, China

Guizhou Provincial People's HospitalRecruiting

Guiyang, 550002, China

The First Affiliated Hospital of Anhui Medical UniversityRecruiting

Hefei, 230032, China

The First People's Hospital of Yunnan ProvinceRecruiting

Kunming, 650032, China

The Second Hospital of NanjingRecruiting

Nanjing, 210003, China

Shanghai Jiaotong University School of Medicine, Renji HospitalRecruiting

Shanghai, 200001, China

The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting

Ürümqi, 830054, China

Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting

Wuhan, 430030, China

The First Affiliated Hospital of PLA Air Force Medical UniversityRecruiting

Xi'an, 710032, China

The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Xi'an, 710061, China

The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Zhejiang, 310009, China

Henan Provincial People's HospitalRecruiting

Zhengzhou, 450003, China

The Third People's Hospital of ZhenjiangRecruiting

Zhenjiang, 212021, China

Fakultni nemocnice OstravaRecruiting

Ostrava, 70852, Czechia

RESEARCH Site s.r.oRecruiting

Pilsen, 301 00, Czechia

Vseobecná fakultni nemocnice v Praze Nemocnicni lekarna odd. HVLP - Klinicke hodnoceni lecivRecruiting

Prague, 128 08, Czechia

Aarhus UniversitetshospitalRecruiting

Aarhus, 8200, Denmark

AP-HP - Hopital AvicenneRecruiting

Bobigny, 93000, France

Hôpital Claude Huriez-Lille-1 Place de VerdunRecruiting

Lille, 59000, France

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Lyon, 69317, France

CHU-Montpellier-Hopital St EloiRecruiting

Montipellier, 34295, France

Hopital Saint Antoine, Assistance Publique-Hopitaux de ParisRecruiting

Paris, 75012, France

AP-HP Hopital Henri MondorRecruiting

Paris, 94000, France

CHU de Strasbourg - Nouvel Hôpital CivilRecruiting

Strasbourg, 67000, France

CHRU de Nancy - Hôpitaux de BraboisRecruiting

Vandœuvre-lès-Nancy, 54500, France

AP-HP - Hôpital Paul BrousseRecruiting

Villejuif, 94804, France

Universitätsklinikum RegensburgRecruiting

Bayern, 93042, Germany

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Berlin, 13353, Germany

Universitatsklinikum des SaarlandesRecruiting

Homburg, 66421, Germany

Gastroenterologisch - Hepatologisches MVZ Kiel GmbHRecruiting

Kiel, 24146, Germany

Evangelismos General HospitalRecruiting

Athens, 106 76, Greece

University General Hospital of LarissaRecruiting

Larissa, 41 110, Greece

General Hospital of Thessaloniki ''Hippokratio''Recruiting

Thessaloniki, 546 41, Greece

Prince of Wales Hospital - Hong KongRecruiting

Hong Kong, 000, Hong Kong

Queen Mary Hospital - PPDSRecruiting

Hong Kong, 999077, Hong Kong

Princess Margaret Hospital - Hong KongRecruiting

Hong Kong, Hong Kong

Semmelweis Egyetem - Sebészeti,Recruiting

Budapest, 1082, Hungary

Somogy Varmegyei Kaposi Mor Oktato KorhazRecruiting

Kaposvár, 7400, Hungary

Soroka University Medical CentreRecruiting

Beersheba, 84101, Israel

Lady Davis Carmel Medical CenterRecruiting

Haifa, 33394, Israel

Liver Unit, institute of Gasteroenterology and Liver DiseasesRecruiting

Jerusalem, 91120, Israel

Rabin Medical Center - PPDSRecruiting

Petah Tikva, 49100, Israel

Rambam Health Care Campus - PPDSRecruiting

Ramat Gan, 52394, Israel

The Chaim Sheba Medical Center - PPDSRecruiting

Ramat Gan, 5266202, Israel

Tel Aviv Sourasky Medical Center IchilovRecruiting

Tel Aviv, 64239, Israel

Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. SalesiRecruiting

Ancona, 60020, Italy

IRCCS Saverio de Bellis-UOSD "Epatopatie"Recruiting

Castellana Grotte, 70013, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting

Milan, 20122, Italy

ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e GastroenterologicoRecruiting

Milan, 20142, Italy

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di BaggiovaraRecruiting

Modena, 41126, Italy

Fondazione IRCCS San Gerardo dei TintoriRecruiting

Monza, 20052, Italy

Azienda Ospedale - Università PadovaRecruiting

Padova, 35100, Italy

A.O.U.P. Paolo Giaccone , U.O.C di GastroeneterologiaRecruiting

Palermo, 90127, Italy

A.O.U. Pisana, U.O. EpatologiaRecruiting

Pisa, 56124, Italy

Ospedale Casa Sollievo Della Sofferenza IRCCSRecruiting

San Giovanni Rotondo, 71013, Italy

Clinica de Higado y Gastroenterologia Integral, S.C.Recruiting

Cuernavaca, 62170, Mexico

PROACTIVE CR MEXICO SA de CVRecruiting

Irapuato, 36650, Mexico

Consultorio Medico - Distrito FederalRecruiting

Mexico City, 6700, Mexico

Centro De Investigacion Y Gastroenterogia, S.C.Recruiting

México, 76806, Mexico

Oaxaca Site Management Organization - Hospital - OSMO - PPDSRecruiting

Oaxaca City, 71256, Mexico

FAICICRecruiting

Veracruz, 91900, Mexico

ID Clinic Arkadiusz PisulaRecruiting

Mysłowice, 41-400, Poland

PlanetMed SP. z. o. oRecruiting

Wroclaw, 52-210, Poland

Centro Clínico Académico, Braga - Hospital de BragaRecruiting

Braga, 4710-243, Portugal

ULS de Matosinhos, EPE - Hospital Pedro HispanoRecruiting

Porto, 4464-513, Portugal

Galenus Group - Puerto RicoRecruiting

Manati, 00674, Puerto Rico

Institutul Clinic FundeniRecruiting

Bucharest, 022328, Romania

National University HospitalRecruiting

Singapore, 119228, Singapore

Singapore General Hospital (SGH)Recruiting

Singapore, 169608, Singapore

Tan Tock Seng HospitalRecruiting

Singapore, 169608, Singapore

Changi General HospitalRecruiting

Singapore, 529889, Singapore

Pusan National University HospitalRecruiting

Busan, 49241, South Korea

Kyungpook National University HospitalRecruiting

Daegu, 41944, South Korea

Chonnam National University HospitalRecruiting

Gwangju, 61455, South Korea

Seoul National University Bundang HospitalRecruiting

Seongnam, 13620, South Korea

Asan Medical CenterRecruiting

Seoul, 05505, South Korea

Korea University Guro HospitalRecruiting

Seoul, 08308, South Korea

Seoul National University HospitalRecruiting

Seoul, 3080, South Korea

Severance Hospital, Yonsei University Health SystemRecruiting

Seoul, 3722, South Korea

Samsung Medical CenterRecruiting

Seoul, 6351, South Korea

The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting

Seoul, 6591, South Korea

Complexo Hospitalario Universitario De SantiagoRecruiting

A Coruña, 15706, Spain

Hospital Universitario Fundacion AlcorconRecruiting

Alcorcón, 28925, Spain

Hospital Universitario Germans Trias i PujolRecruiting

Badalona, 08916, Spain

Hospital del MarRecruiting

Barcelona, 08003, Spain

Hospital Universitario Vall d'Hebron-VIHRRecruiting

Barcelona, 08035, Spain

Hospital Clinic de BarcelonaRecruiting

Barcelona, 08036, Spain

C.H. Regional Reina Sofia - PPDSRecruiting

Córdoba, 14004, Spain

Hospital Universitario Virgen de la VictoriaRecruiting

Málaga, 29010, Spain

Hospital Universitario Marques de ValdecillaRecruiting

Santander, 39008, Spain

Hospital Universitario Virgen del Rocio - PPDSRecruiting

Seville, 41010, Spain

Universitätsspital BernRecruiting

Bern, 3010, Switzerland

Universitätsspital ZürichRecruiting

Zurich, 8091, Switzerland

Chiayi Christian HospitalRecruiting

Chiayi City, Taiwan

Kaohsiung Medical University HospitalRecruiting

Kaohsiung City, 80756, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial HospitalRecruiting

Kaohsiung City, 83301, Taiwan

National Cheng Kung University HospitalRecruiting

Tainan, 70403, Taiwan

National Taiwan University HospitalRecruiting

Taipei, 10002, Taiwan

Taipei Veterans General HospitalRecruiting

Taipei, 112, Taiwan

Chang Gung Memorial Hospital, LinkouRecruiting

Taoyuan, 33305, Taiwan

Adana City Training and Research HospitalRecruiting

Adana, 1370, Turkey (Türkiye)

Ankara Bilkent City HospitalRecruiting

Ankara, 06800, Turkey (Türkiye)

Gaziantep University Medical Faculty Sahinbey Research and Practice HospitalRecruiting

Gaziantep, 27630, Turkey (Türkiye)

Uludag University Medical FacultyRecruiting

Görükle, 16059, Turkey (Türkiye)

Ege UniversityRecruiting

Izmir, 35040, Turkey (Türkiye)

Katip Celebi UniversityRecruiting

Karabağlar, 35150, Turkey (Türkiye)

Kocaeli University Medical Faculty HospitalRecruiting

Kocaeli, 41380, Turkey (Türkiye)

Mersin Universitesi Tip Fakultesi HastanesiRecruiting

Mersin, 33110, Turkey (Türkiye)

Marmara University Pendik Training and Research HospitalRecruiting

Pendik, 34899, Turkey (Türkiye)

Rize Recep Tayyip Erdogan University Training and Research HospitalRecruiting

Rize Merkez, 53020, Turkey (Türkiye)

Hull Royal InfirmaryRecruiting

Hull, HU32JZ, United Kingdom

East Suffolk and North Essex NHS Foundation Trust, Ipswich HospitalRecruiting

Ipswich, IP4 5PD, United Kingdom

St James's University Hospital - PPDSRecruiting

Leeds, LS9 7TF, United Kingdom

The Royal London HospitalRecruiting

London, E1 1BB, United Kingdom

Royal Free HospitalRecruiting

London, NW2 2QG, United Kingdom

King's College HospitalRecruiting

London, SE5 9RS, United Kingdom

Freeman HospitalRecruiting

Newcastle upon Tyne, NE7 7DN, United Kingdom

John Radcliffe HospitalRecruiting

Oxford, OX3 9DU, United Kingdom

Sheffield teaching hospital NHS foundation trustRecruiting

Sheffield, S10 2JF, United Kingdom

New Cross HospitalRecruiting

Wolverhampton, WV10 0QP, United Kingdom