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NCT06051617PHASE3Recruiting

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

Gilead Sciences

Start Date

9/7/2023

Completion Date

8/1/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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) ≤ 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

Interventions

DRUG

Seladelpar

DRUG

Placebo

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Conditions

Primary Biliary Cholangitis

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

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

Phoenix, Arizona 85013

United States

OM Research LLC

Lancaster, California 93534

United States

SCPMG/Kaiser Permanente Los Angeles Medical Center

Los Angeles, California 90027

United States

Cedar Sinai Medical Center

Los Angeles, California 90048

United States

California Liver Research Institute

Pasadena, California 91105

United States

Stanford University

Redwood City, California 94063

United States

University of California, Davis Medical Center

Sacramento, California 95817

United States

California Pacific Medical Center - Sutter Pacific Medical Foundation

San Francisco, California 94109

United States

Connie Frank Transplant Center at UCSF

San Francisco, California 94143

United States

Kaiser Permanente - South San Francisco Medical Center

South San Francisco, California 94080

United States

Covenant Metabolic Specialists, LLC

Fort Myers, Florida 33912

United States

Schiff Center for Liver Diseases/University of Miami

Miami, Florida 33136

United States

Covenant Metabolic Specialists, LLC

Sarasota, Florida 33912

United States

Florida Research Institute

Tampa, Florida 34211

United States

Piedmont Atlanta Hospital / Piedmont Transplant Institute

Atlanta, Georgia 30309

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa 52242

United States

University of Louisville, Clinical Trials Unit

Louisville, Kentucky 40202

United States

Ochsner Clinic Foundation

Jefferson, Louisiana 70121

United States

University Health System - East Jefferson General Hospital Campus

New Orleans, Louisiana 70112

United States

Mercy Medical Center

Baltimore, Maryland 21202

United States

Walter Reed National Military

Bethesda, Maryland 20889

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Henry Ford Medical Center - Columbus

Detroit, Michigan 48202

United States

University of Rochester Medical Center - Strong Memorial Hospital

Rochester, Minnesota 14642

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Northwell Health Center for Liver Disease and Transplantation

Manhasset, New York 11030

United States

NYU Langone Health

New York, New York 10016

United States

Mount Sinai

New York, New York 10029

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

University Hosptials Cleveland Medical Center

Cleveland, Ohio 44106

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

The Ohio State University Medical Center

Columbus, Ohio 43210

United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

UPMC Center for Liver Diseases

Pittsburgh, Pennsylvania 15213

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Gastro One

Cordova, Tennessee 38018

United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas 75203

United States

University of Texas Southwestern Medical Center, Professional Office Building One

Dallas, Texas 75390

United States

Soma Clinical Trials

Denison, Texas 75020

United States

American Research Corporation

San Antonio, Texas 78215

United States

Pinnacle Clinical Research, PLLC

San Antonio, Texas 78229

United States

MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax

Fairfax, Virginia 22031

United States

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

Newport News, Virginia 23602

United States

VCU Health Clinical Research Services Unit (CRSU)

Richmond, Virginia 23298

United States

Liver Institute Northwest

Seattle, Washington 98105

United States

Hospital Italiano de Buenos Aires

Buenos Aires, 1181

Argentina

Consultorios Médicos Dr. Doreski - PPDS

Buenos Aires, 1426

Argentina

Buenos Aires Mácula

Buenos Aires, C1061

Argentina

Centro de Investigación y Prevención Cardiovascular

Buenos Aires, C1061

Argentina

AES - AS - Glenny Corp. S.A. Buenos Aires

Buenos Aires, C1430

Argentina

Higea S.A.

Mendoza, M5500

Argentina

DIM Clinica Privada

Ramos Mejía, 1704

Argentina

CINME S.A. - Centro de Investigaciones Metabólicas

Recoleta, C1118AAT

Argentina

Hospital Provincial Del Centenario

Rosario, 2000

Argentina

Princess Alexandra Hospital

Queensland, Queensland 4102

Australia

Flinders Medical Center

Adelaide, South Australia 5042

Australia

Monash Health, Monash Medical Centre

Clayton, Victoria 3168

Australia

Northern Health

Epping, Victoria 3076

Australia

Alfred Hospital

Melbourne, Victoria 3004

Australia

Landeskrankenhaus Hall

Hall in Tirol, 6060

Austria

Krankenhaus der Barmherzigen Brüder

Vienna, 1020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

Klinikum Wels-Grieskirchen GmbH - Standort Wels

Wels, 4600

Austria

UZ Antwerpen

Edegem, 2650

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven - PPDS

Leuven, 3000

Belgium

University of Calgary

Calgary, T2N 4Z6

Canada

University of Alberta

Edmonton, T6G 2B7

Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, H2L 4M1

Canada

Ottawa Hospital

Ottawa, K1H 8L6

Canada

Diex Recherche - Québec - PPDS

Québec, G1V 4T3

Canada

Toronto General Hospital

Toronto, M5G 2C4

Canada

GI Research Institute Foundation

Vancouver, V6G 2Z6

Canada

Centro de Investigación y Prevención Cardiovascular

La Serena, 1720506

Chile

Pontificia Universidad Católica de Chile

Santiago, 8320000

Chile

BIOCINETIC Ltda

Santiago, 8330336

Chile

Clinical Research Chile SpA - PPDS

Valdivia, 5110683

Chile

Beijing Youan Hospital, Capital Medical University

Beijing, 100000

China

Beijing Ditan Hospital, Capital Medical University

Beijing, 100015

China

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050

China

The First Hospital of Jilin University

Changchun, 130021

China

West China Hospital of Sichuan University

Chengdu, 610047

China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, 401336

China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou,

China

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, 510630

China

Guizhou Provincial People's Hospital

Guiyang, 550002

China

The First Affiliated Hospital of Anhui Medical University

Hefei, 230032

China

The First People's Hospital of Yunnan Province

Kunming, 650032

China

The Second Hospital of Nanjing

Nanjing, 210003

China

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, 200001

China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, 830054

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030

China

The First Affiliated Hospital of PLA Air Force Medical University

Xi'an, 710032

China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang, 310009

China

Henan Provincial People's Hospital

Zhengzhou, 450003

China

The Third People's Hospital of Zhenjiang

Zhenjiang, 212021

China

Fakultni nemocnice Ostrava

Ostrava, 70852

Czechia

RESEARCH Site s.r.o

Pilsen, 301 00

Czechia

Aarhus Universitetshospital

Aarhus, 8200

Denmark

AP-HP - Hopital Avicenne

Bobigny, 93000

France

Hôpital Claude Huriez-Lille-1 Place de Verdun

Lille, 59000

France

Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse

Lyon, 69317

France

CHU-Montpellier-Hopital St Eloi

Montipellier, 34295

France

Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris

Paris, 75012

France

AP-HP Hopital Henri Mondor

Paris, 94000

France

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67000

France

CHRU de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54500

France

Charité Campus Virchow-Klinikum-Augustenburger Platz 1

Berlin, 13353

Germany

Universitatsklinikum des Saarlandes

Homburg, 66421

Germany

Gastroenterologisch - Hepatologisches MVZ Kiel GmbH

Kiel, 24146

Germany

Evangelismos General Hospital

Athens, 106 76

Greece

University General Hospital of Larissa

Larissa, 41 110

Greece

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, 546 41

Greece

Prince of Wales Hospital - Hong Kong

Hong Kong, 000

Hong Kong

Queen Mary Hospital - PPDS

Hong Kong, 999077

Hong Kong

Princess Margaret Hospital - Hong Kong

Hong Kong,

Hong Kong

Semmelweis Egyetem - Sebészeti,

Budapest, 1082

Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400

Hungary

Soroka University Medical Centre

Beersheba, 84101

Israel

Lady Davis Carmel Medical Center

Haifa, 33394

Israel

Liver Unit, institute of Gasteroenterology and Liver Diseases

Jerusalem, 91120

Israel

Rabin Medical Center - PPDS

Petah Tikva, 49100

Israel

Rambam Health Care Campus - PPDS

Ramat Gan, 52394

Israel

The Chaim Sheba Medical Center - PPDS

Ramat Gan, 5266202

Israel

Tel Aviv Sourasky Medical Center Ichilov

Tel Aviv, 64239

Israel

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

Ancona, 60020

Italy

IRCCS Saverio de Bellis-UOSD "Epatopatie"

Castellana Grotte, 70013

Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

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

Milan, 20142

Italy

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Modena, 41126

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, 20052

Italy

Azienda Ospedale - Università Padova

Padova, 35100

Italy

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

Palermo, 90127

Italy

A.O.U. Pisana, U.O. Epatologia

Pisa, 56124

Italy

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, 71013

Italy

Clinica de Higado y Gastroenterologia Integral, S.C.

Cuernavaca, 62170

Mexico

PROACTIVE CR MEXICO SA de CV

Irapuato, 36650

Mexico

Consultorio Medico - Distrito Federal

Mexico City, 6700

Mexico

Centro De Investigacion Y Gastroenterogia, S.C.

México, 76806

Mexico

Oaxaca Site Management Organization - Hospital - OSMO - PPDS

Oaxaca City, 71256

Mexico

FAICIC

Veracruz, 91900

Mexico

ID Clinic Arkadiusz Pisula

Mysłowice, 41-400

Poland

PlanetMed SP. z. o. o

Wroclaw, 52-210

Poland

Galenus Group - Puerto Rico

Manati, 00674

Puerto Rico

Institutul Clinic Fundeni

Bucharest, 022328

Romania

National University Hospital

Singapore, 119228

Singapore

Singapore General Hospital (SGH)

Singapore, 308433

Singapore

Tan Tock Seng Hospital

Singapore, 308433

Singapore

Changi General Hospital

Singapore, 529889

Singapore

Pusan National University Hospital

Busan, 49241

South Korea

Kyungpook National University Hospital

Daegu, 41944

South Korea

Chonnam National University Hospital

Gwangju, 61455

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Seoul National University Hospital

Seoul, 3080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 3722

South Korea

Samsung Medical Center

Seoul, 6351

South Korea

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

Seoul, 6591

South Korea

Complexo Hospitalario Universitario De Santiago

A Coruña, 15706

Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, 28925

Spain

Hospital Universitario Germans Trias i Pujol

Badalona, 08916

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitario Vall d'Hebron-VIHR

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Universitario Marques de Valdecilla

Santander, 39008

Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41010

Spain

Universitätsspital Bern

Bern, 3010

Switzerland

Universitätsspital Zürich

Zurich, 8091

Switzerland

Chiayi Christian Hospital

Chiayi City,

Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, 80756

Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, 33305

Taiwan

Adana City Training and Research Hospital

Adana, 1370

Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, 06800

Turkey (Türkiye)

Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital

Gaziantep, 27630

Turkey (Türkiye)

Uludag University Medical Faculty

Görükle, 16059

Turkey (Türkiye)

Ege University

Izmir, 35040

Turkey (Türkiye)

Katip Celebi University

Karabağlar, 35150

Turkey (Türkiye)

Kocaeli University Medical Faculty Hospital

Kocaeli, 41380

Turkey (Türkiye)

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, 33110

Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Pendik, 34899

Turkey (Türkiye)

Rize Recep Tayyip Erdogan University Training and Research Hospital

Rize Merkez, 53020

Turkey (Türkiye)

Hull Royal Infirmary

Hull, HU32JZ

United Kingdom

East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital

Ipswich, IP4 5PD

United Kingdom

St James's University Hospital - PPDS

Leeds, LS9 7TF

United Kingdom

The Royal London Hospital

London, E1 1BB

United Kingdom

Royal Free Hospital

London, NW2 2QG

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom

John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom

Sheffield teaching hospital NHS foundation trust

Sheffield, S10 2JF

United Kingdom

New Cross Hospital

Wolverhampton, WV10 0QP

United Kingdom