Study Details

Participation Requirements

Age

18 Years - 75 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Primary Biliary Cirrhosis

Gender

N/A

Date

December 2017 - November 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule

Eligibility Information

Inclusion Criteria

1. Must have given written informed consent (signed and dated)
2. Participated in a PBC study with seladelpar
3. Females of reproductive potential must use at least one 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

Exclusion Criteria

Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption.
1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
3. AST or ALT above 3 × the upper limit of normal (ULN)
4. Total bilirubin above 2 × ULN
5. MELD score ≥ 12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
8. Auto-immune hepatitis
9. Primary sclerosing cholangitis
10. Known history of alpha-1-antitrypsin deficiency
11. Known history of chronic viral hepatitis
12. For females, pregnancy or breast-feeding
13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
14. Current use of fibrates or use of fibrates within 3 months prior to Screening
15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
19. Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the Investigator
20. Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
22. Positive for:
1. Hepatitis B, defined as the presence of hepatitis B surface antigen
2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
3. Human immunodeficiency virus (HIV) antibody
23. Active COVID-19 infection during screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (108)

Arkansas Diagnostic Center

Little Rock, Arkansas, United States, 72205

Stanford University School of Medicine

Palo Alto, California, United States, 94305

California Liver Research Institute

Pasadena, California, United States, 91105

University of California Davis Medical Center

Sacramento, California, United States, 95817

California Pacific Medical Center

San Francisco, California, United States, 94115

University of Colorado - Denver - PPDS

Aurora, Colorado, United States, 80045

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

Covenant Research Fort Myers

Fort Myers, Florida, United States, 33606

Florida Digestive Health Specialist

Lakewood Rch, Florida, United States, 34211

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

Covenant Research, LLC

Sarasota, Florida, United States, 33912

Digestive Healthcare of Georgia PC

Atlanta, Georgia, United States, 30309

University of Chicago Hospitals

Chicago, Illinois, United States, 60637

East Jefferson General Hospital

New Orleans, Louisiana, United States, 70112

Mercy Medical Center (Baltimore)

Baltimore, Maryland, United States, 21202

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center - 330 Brookline Ave

Boston, Massachusetts, United States, 02215

Henry Ford Health System

Novi, Michigan, United States, 48377

MNGI Digestive Health PA-Plymouth

Minneapolis, Minnesota, United States, 55413

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States, 39157

Saint Louis University

St Louis, Missouri, United States, 63104

NYU Langone Medical Center

New York, New York, United States, 10021

Weill Cornell Medical College

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

University of Rochester Medical Center - PPDS

Rochester, New York, United States, 14642

Duke University Medical Center

Durham, North Carolina, United States, 27710

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, United States, 18017

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Galen Medical Group

Chattanooga, Tennessee, United States, 37404

Gastro One-8110 Walnut Run Rd

Cordova, Tennessee, United States, 38018

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 39090

Liver Institute at Methodist Dallas

Dallas, Texas, United States, 75203

Baylor College of Medicine

Houston, Texas, United States, 77030

The Texas Liver Institute - 607 Camden St

San Antonio, Texas, United States, 78215 1619

Pinnacle Clinical Research, PLLC

San Antonio, Texas, United States, 78229

Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads

Newport News, Virginia, United States, 23602

Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond

Richmond, Virginia, United States, 23226

Liver Institute Northwest, PLLC

Seattle, Washington, United States, 98195

CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278

Balvanera, Argentina, C1056ABJ

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina, 1181

DIM Clínica Privada

El Palomar, Argentina, 1684

Hospital Italiano de La Plata

La Plata, Argentina, B1902AWL

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia, 4029

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Klinikum Wels-Grieskirchen GmbH - Standort Wels

Wels, Austria, 4710

UZ Gent

Ghent, Belgium, 9000

UZ Leuven

Leuven, Belgium, 3000

University of Calgary Medicine

Calgary, Canada, T2N 4Z6

Toronto General Hospital

Toronto, Canada, M5G 2C4

Centro Clinico Mediterraneo

La Serena, Chile, 1720506

Fakultni nemocnice Ostrava

Ostrava, Czechia, 708 00

Hospices Civils de Lyon - Hôpital de La Croix Rousse

Lyon, France, 69004

AP-HP - Hôpital Saint Antoine

Paris, France, 75012

Charité - Universitätsmedizin Berlin

Berlin, Germany, 10117

Universitatsklinkum Erlangen-Ulmenweg 18

Erlangen, Germany, 91054

ifi-Institute for Interdisciplinary Medicine

Hamburg, Germany, 20099

Gastroenterologische Gemeinschaftspraxis Herne

Herne, Germany, 44623

Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134

Kiel, Germany, 24146

Universitätsklinikum Tübingen

Tübingen, Germany, 72076

University General Hospital of Larissa

Larissa, Greece, 411 10

Semmelweis Egyetem

Budapest, Hungary, 1082

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary, 7400

Carmel Medical Center

Haifa, Israel, 34462

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, Israel, 91120

The Chaim Sheba Medical Center - PPDS

Tel Aviv, Israel, 5262100

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv, Israel, 6423906

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Modena, Italy, 41126

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2

Palermo, Italy, 90127

Fondazione IRCCS San Gerardo dei Tintori

Rozzano, Italy, 20089

Consultorio de la Doctora Maria Sarai Gonzalez Huezo

Metepec, Mexico, 52120

Consultorio Medico - Distrito Federal

Roma Norte, Mexico, 06700

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands, 6525 GA

Christchurch Hospital

Christchurch, New Zealand, 4710

Dunedin Hospital

Dunedin, New Zealand, 9012

Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

Katowice, Poland, 40-752

ID Clinic Arkadiusz Pisula

Mysłowice, Poland, 41-400

Fundeni Clinical Institute

Bucharest, Romania, 22328

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea, 14584

Inje University Busan Paik Hospital

Busan, South Korea, 47392

Pusan National University Hospital

Busan, South Korea, 49241

Kyungpook National University Hospital

Daegu, South Korea, 41944

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Seoul National University Hospital

Seoul, South Korea, 03080

Asan Medical Center

Songpa-Gu, South Korea, 05505

Hospital Universitario Germans Trias i Pujol

Badalona, Spain, 08916

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 8036

Hospital Universitario La Paz - PPDS

Horcajo de la Sierra, Spain, 28755

Hospital Universitario 12 de Octubre

Madrid, Spain, 28026

Hospital Universitario Virgen de la Victoria

Málaga, Spain, 29010

Hospital Universitario Marques de Valdecilla

Santander, Spain, 39008

Universitätsspital Zürich

Zurich, Switzerland, 8091

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye), 6590

Ege Universitesi Tip Fakultesi Hastanesi

Bornova, Turkey (Türkiye), 35100

Ankara Bilkent City Hospital

Çankaya, Turkey (Türkiye), 06800

Marmara University Pendik Training and Research Hospital

Maltepe, Turkey (Türkiye), 34840

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Topkapı, Turkey (Türkiye), 34093

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom, B15 2TH

Hull Royal Infirmary

Hull, United Kingdom, HU3 2JZ

Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

London, United Kingdom, E1 1BB

King's College Hospital

London, United Kingdom, SE5 9RS

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom, NE4 6BE

Queen's Medical Centre

Nottingham, United Kingdom, NG7 2UH

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Queen Alexandra Hospital

Portsmouth, United Kingdom, PO6 3LY

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

OVERVIEW

PROTOCOL SUMMARY