Study Details

Participation Requirements

Age

18 Years - 75 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Primary Sclerosing Cholangitis

Gender

N/A

Date

March 2019 - November 2022

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Cilofexor, Placebo

Eligibility Information

Inclusion Criteria

Diagnosis of large duct PSC
Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:
Platelet count ≥ 150,000/mm^3
Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
Negative anti-mitochondrial antibody

Exclusion Criteria

Current or prior history of any of the following:
Cirrhosis
Liver transplantation
Cholangiocarcinoma or hepatocellular carcinoma (HCC)
Ascending cholangitis within 30 days of screening
Presence of a percutaneous drain or biliary stent
Other causes of liver disease
Current or prior history of unstable cardiovascular disease
Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (201)

Institute For Liver Health

Glendale, Arizona, United States, 85306

The Institute for Liver Heath

Phoenix, Arizona, United States, 85013

Southern California Research Center

Coronado, California, United States, 92118

Altman Clinical and Translational Research Institute (Clinic)

La Jolla, California, United States, 92037

Scripps Clinic/Green Hospital

La Jolla, California, United States, 92037

Ruane Clinical Research Group Inc.

Los Angeles, California, United States, 90036

Stanford Hospital

Palo Alto, California, United States, 94025

California Liver Research Institute

Pasadena, California, United States, 91105

University of California, Davis Medical Center (study visits)

Sacramento, California, United States, 95817

Sutter Pacific Medical Foundation - California Pacific Medical Center

San Francisco, California, United States, 94107

University of California, San Francisco Liver Clinic

San Francisco, California, United States, 94143

Cedars Sinai Medical Center

West Hollywood, California, United States, 90048

University of Colorado Denver and Hospital

Aurora, Colorado, United States, 80045

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States, 80907

South Denver Gastroenterology, PC

Englewood, Colorado, United States, 80113

Yale School of Medicine

New Haven, Connecticut, United States, 48109

MedStar Georgetown University Hospital

Washington, District of Columbia, United States, 20007

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States, 33136

Advanced Research Institute, Inc

New Port Richey, Florida, United States, 34653

Advanced Medical Research Center

Port Orange, Florida, United States, 32127

Cleveland Clinic Florida

Weston, Florida, United States, 33331

Piedmont Atlanta Hospital

Atlanta, Georgia, United States, 30309

Northwestern Memorial Hospital; Clinical Research Unit

Chicago, Illinois, United States, 60611

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Chicago Medical Center (outpatient clinic)

Chicago, Illinois, United States, 60637

NorthShore University Healthsystem

Evanston, Illinois, United States, 60201

IU Health University Hospital

Indianapolis, Indiana, United States, 46202

University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Louisiana Research Center, LLC

Shreveport, Louisiana, United States, 71105

Mercy Medical Center

Baltimore, Maryland, United States, 21202

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

NECCR PrimaCare Research, LLC

Fall River, Massachusetts, United States, 02721

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, United States, 48109

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Minnesota Gastroenterology, PA

Maplewood, Minnesota, United States, 55117

Mayo Clinic

Rochester, Minnesota, United States, 55905

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States, 39157

Saint Louis University, Gastroenterology & Hepatology

Saint Louis, Missouri, United States, 63104

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68105

Rutgers New Jersey Medical School - Doctors Office Center

Newark, New Jersey, United States, 07103

Montefiore Medical Center

Bronx, New York, United States, 10467

Northwell Health Center for Liver Diseases and Transplantation

Manhasset, New York, United States, 11030

NYU Langone Health

New York, New York, United States, 10016

Weill Cornell Medical College

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai Beth Israel

New York, New York, United States, 10029

Mount Sinai Medical Center

New York, New York, United States, 10029

Center for Liver Disease and Transplantation, Columbia University Medical Center

New York, New York, United States, 10032

University of Rochester Medical Center

Rochester, New York, United States, 14642

The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

Chapel Hill, North Carolina, United States, 27599

Carolinas Medical Center - Center for Liver Disease

Charlotte, North Carolina, United States, 28204

Duke University Medical Center

Durham, North Carolina, United States, 27710

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

Holmes Hospital

Cincinnati, Ohio, United States, 45267

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Einstein Medical Center

Philadelphia, Pennsylvania, United States, 19141

Reading Hospital

West Reading, Pennsylvania, United States, 19611

University Gastroenterology

Providence, Rhode Island, United States, 02905

Medical University of South Carolina

Charleston, South Carolina, United States, 28204

Rapid City Medical Center, LLP

Rapid City, South Dakota, United States, 57701

Methodist University Hospital

Memphis, Tennessee, United States, 38104

Vanderbilt University Medical Center - Digestive Disease Center

Nashville, Tennessee, United States, 37232

Texas Clinical Research Institute

Arlington, Texas, United States, 76012

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States, 75203

Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas

Dallas, Texas, United States, 75246

Baylor Scott & White Medical Center at Fort Worth

Fort Worth, Texas, United States, 76104

Baylor College of Medicine - Advanced Liver Therapies

Houston, Texas, United States, 77030

Spring Gastroenterology Associates

Humble, Texas, United States, 77338

San Antonio Military Medical Center, Gastro/Hepatology

San Antonio, Texas, United States, 78234

Intermountain Medical Center - Transplant Services

Murray, Utah, United States, 84107

University of Utah Hospital

Salt Lake City, Utah, United States, 84132

The University of Vermont Medical Center

Burlington, Vermont, United States, 05401

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22908

Verity Research Inc.

Fairfax, Virginia, United States, 22031

Bon Secours Richmond Community Hospital

Richmond, Virginia, United States, 23226

Virginia Commonwealth University Clinical Research Services Unit

Richmond, Virginia, United States, 23298

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Harborview Medical Center

Seattle, Washington, United States, 98104

Liver Institute Northwest

Seattle, Washington, United States, 98105

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

Nepean Hospital

Penrith, New South Wales, Australia, 2751

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Coral Sea Clinical Research Institute - Mackay

Auchenflower, Queensland, Australia, 4066

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia, 4029

Mater Misericordiae Ltd

South Brisbane, Queensland, Australia, 4101

Monash Health

Clayton, Victoria, Australia, 3168

Austin Health

Heidelberg, Victoria, Australia, 3084

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee

Klagenfurt am Wörthersee, Austria, 9020

Allgemeines Krankenhaus Wien

Vienna, Austria, 1090

Hôpital Erasme - ULB

Bruxelles, Belgium, 10070

Universitair Ziekenhuis Antwerpen

Edegem, Belgium, 2650

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Algemeen Ziekenhuis Maria Middelares

Ghent, Belgium, 9000

Universitair Ziekenhuis Leuven

Leuven, Belgium, B-3000

Centre Hospitalier Universitaire de Liège Site Sart Tilman

Liege, Belgium, 4000

William Osler Health System - Brampton Civic Hospital

Brampton, Canada, L6R 3J7

University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

Calgary, Canada, T2N 4Z6

University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

Edmonton, Canada, T6G 2X8

Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

Halifax, Canada, B3L 1E4

St. Joseph's Healthcare Hamilton

Hamilton, Canada, L8N 4A6

McMaster University Medical Center

Hamilton, Canada, L8S 4L8

Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

Montreal, Canada, H2X 3J4

Chronic Viral Illness Service/McGill University Health Centre (MUHC)

Montreal, Canada, H4A 3J1

Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

Toronto, Canada, M5G 2C4

Toronto Liver Centre

Toronto, Canada, M6H 3M1

Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

Vancouver, Canada, V5Z 1M9

(G.I.R.I.) GI Research Institute

Vancouver, Canada, V6Z 2K5

University of Manitoba/Health Sciences Centre

Winnipeg, Canada, R3E 3P4

Aalborg University Hospital

Aalborg, Denmark, 9000

Copenhagen University Hospital - Hvidovre

København Ø, Denmark, DK-2100

Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala

Helsinki, Finland, 00290

Turku University Hospital, Gastroenterology Outpatient Clinic

Turku, Finland, 20520

Hôpital Saint-Eloi

Montpellier cedex 5, Herault, France, 34295

CHU Amiens-Picardie Hôpital Sud

Amiens, France, 80054

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

CHRU Lille, France, 59000

Hôpital Henri Mondor

Creteil, France, 94010

CHU Grenoble Alpes

Grenoble cedex 09, France, 38043

Hôpital Saint-Joseph

Marseille, France, 13008

Hopital Saint Antoine

Paris, France, 75571

CHU Bordeaux-Hopital Haut-Leveque

Pessac, France, 33604

Hopital Robert Debré - Centre Hospitalier Universitaire de Reims

Reims, France, 4025

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, France, 67091

CHU de Toulouse Hopital Ranguiel

Toulouse cedex, France, 31059

CHU de Toulouse - Hopital Rangueil

Toulouse, France, 31300

Hopital Paul Brousse

Villejuif, France, 94800

GASTRO-Studien GbR

Berlin, Germany, 10825

Universitätsklinikum Essen

Essen, Germany, 45147

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany, 60590

Medizinische Hochscule Hannover

Hannover, Germany, 30625

Universitätsklinik Heidelberg

Heidelberg, Germany, 69120

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie

Homburg, Germany, 66421

Gastroenterologisch-Hepatologisches Zentrum Kiel

Kiel, Germany, 24146

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Germany, 55131

Universitätsmedizin Mannheim, II. Medizinische Klinik

Mannheim, Germany, 68167

Emek Medical Center

Afula, Israel, 1834111

Rambam Health Care Campus

Haifa, Israel, 31096

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel, 64239

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 91120

Rabin Medical Center

Petah Tikva, Israel, 49100

The Chaim Sheba Medical Center

Ramat Gan, Israel, 5265601

Tel Aviv Sourasky Medical Center

Tel-Aviv, Israel, 62431

IRCCS Ospedale Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy, 71013

Dipartimento Gastroenterologico e dei Trapianti

Ancona, Italy, 60126

Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara

Bologna, Italy, 40138

Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia

Milan, Italy, 20122

Medicina Interna 1

Novara, Italy, 28100

Azienda Ospedale Universita Padova

Padova, Italy, 35128

Azienda Ospedaliera Universitaria Policlinico P. Giaccone

Palermo, Italy, 90127

Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia

Pisa, Italy, 56124

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy, 00168

Istituto Clinico Humanitas - Unita Operativa di Epatologia

Rozzano (Milan), Italy, 20089

U.O.C. Gatroenterologia

Rozzano, Italy, 20089

Chiba University Hospital

Chiba-shi, Japan, 260-8670

Hiroshima University Hospital

Hiroshima, Japan, 7348551

National Hospital Organization Nagasaki Medical Center

Nagasaki, Japan, 856-8562

Okayama University Hospital

Okayama-shi, Japan, 7008558

National University Corporation Tohoku University Tohoku University Hospital

Sendai, Japan, 980-8574

Osaka University Hospital

Suita, Japan, 565-0871

Juntendo University Hospital

Tokyo, Japan, 113-8431

Teikyo University Hospital

Tokyo, Japan, 173-8606

Ehime University Hospital

Toon-Shi, Japan, 791-0295

Yamagata University Hospital

Yamagata, Japan, 9909585

Auckland City Hospital

Auckland, New Zealand, 92103

Christchurch Hospital

Christchurch, New Zealand, 8011

Waikato Hospital

Hamilton, New Zealand, 2001

Hospital General Universitario de Alicante

Alicante, Spain, 3010

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Hospital Universitario Ramon y cajal

Madrid, Spain, 28034

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain, 28220

Complejo Hospitalario de Pontevedra

Pontevedra, Spain, 36071

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, Spain, 15706

Hospital General Universitario de Valencia

Valencia, Spain, 46010

Hospital Universitari Politecnic La Fe de Valencia

Valencia, Spain, 46026

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Universitatsspital Bern

Bern, Switzerland, 3010

Epatocentro Ticino SA

Lugano, Switzerland, 6900

Universitatsspital Zurich

Zurich, Switzerland, 8091

University Hospital Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2TT

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, G4 0SF

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Aintree University Hospitals NHS Foundation Trust

Liverpool, United Kingdom, L9 7AL

Barts Health NHS Trust

London, United Kingdom, E1 1BB

Royal Free London NHS Foundation Trust

London, United Kingdom, NW3 2QG

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9NT

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom, SW10 9NH

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG7 2UH

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 9DU

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom, PO6 3LY

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis (PRIMIS)

OVERVIEW

PROTOCOL SUMMARY