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ACTIVE NOT RECRUITING

NCT03301506

PHASE3

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Official title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2017-12-12

Completion Date

2028-11

Last Updated

2025-12-23

Healthy Volunteers

Conditions

Primary Biliary Cirrhosis

Interventions

DRUG

Seladelpar 5 mg Capsule

Participants will be assigned to a treatment group if tolerability issues noted in the previous study.

DRUG

Seladelpar 10 mg Capsule

Participants will be assigned to a treatment group unless there are tolerability issues.

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 (108)

Arkansas Diagnostic Center

Little Rock, Arkansas, United States

Stanford University School of Medicine

Palo Alto, California, United States

California Liver Research Institute

Pasadena, California, United States

University of California Davis Medical Center

Sacramento, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of Colorado - Denver - PPDS

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Covenant Research Fort Myers

Fort Myers, Florida, United States

Florida Digestive Health Specialist

Lakewood Rch, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Covenant Research, LLC

Sarasota, Florida, United States

Digestive Healthcare of Georgia PC

Atlanta, Georgia, United States

University of Chicago Hospitals

Chicago, Illinois, United States

East Jefferson General Hospital

New Orleans, Louisiana, United States

Mercy Medical Center (Baltimore)

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center - 330 Brookline Ave

Boston, Massachusetts, United States

Henry Ford Health System

Novi, Michigan, United States

MNGI Digestive Health PA-Plymouth

Minneapolis, Minnesota, United States

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States

Saint Louis University

St Louis, Missouri, United States

NYU Langone Medical Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester Medical Center - PPDS

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Galen Medical Group

Chattanooga, Tennessee, United States

Gastro One-8110 Walnut Run Rd

Cordova, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The Texas Liver Institute - 607 Camden St

San Antonio, Texas, United States

Pinnacle Clinical Research, PLLC

San Antonio, Texas, United States

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

Newport News, Virginia, United States

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

Richmond, Virginia, United States

Liver Institute Northwest, PLLC

Seattle, Washington, United States

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

Balvanera, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

DIM Clínica Privada

El Palomar, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Klinikum Wels-Grieskirchen GmbH - Standort Wels

Wels, Austria

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

University of Calgary Medicine

Calgary, Canada

Toronto General Hospital

Toronto, Canada

Centro Clinico Mediterraneo

La Serena, Chile

Fakultni nemocnice Ostrava

Ostrava, Czechia

Hospices Civils de Lyon - Hôpital de La Croix Rousse

Lyon, France

AP-HP - Hôpital Saint Antoine

Paris, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitatsklinkum Erlangen-Ulmenweg 18

Erlangen, Germany

ifi-Institute for Interdisciplinary Medicine

Hamburg, Germany

Gastroenterologische Gemeinschaftspraxis Herne

Herne, Germany

Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134

Kiel, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

University General Hospital of Larissa

Larissa, Greece

Semmelweis Egyetem

Budapest, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Carmel Medical Center

Haifa, Israel

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, Israel

The Chaim Sheba Medical Center - PPDS

Tel Aviv, Israel

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv, Israel

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Modena, Italy

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

Palermo, Italy

Fondazione IRCCS San Gerardo dei Tintori

Rozzano, Italy

Consultorio de la Doctora Maria Sarai Gonzalez Huezo

Metepec, Mexico

Consultorio Medico - Distrito Federal

Roma Norte, Mexico

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Christchurch Hospital

Christchurch, New Zealand

Dunedin Hospital

Dunedin, New Zealand

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

Katowice, Poland

ID Clinic Arkadiusz Pisula

Mysłowice, Poland

Fundeni Clinical Institute

Bucharest, Romania

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Songpa-Gu, South Korea

Hospital Universitario Germans Trias i Pujol

Badalona, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario La Paz - PPDS

Horcajo de la Sierra, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Universitätsspital Zürich

Zurich, Switzerland

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Bornova, Turkey (Türkiye)

Ankara Bilkent City Hospital

Çankaya, Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Maltepe, Turkey (Türkiye)

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Topkapı, Turkey (Türkiye)

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

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

London, United Kingdom

King's College Hospital

London, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Queen's Medical Centre

Nottingham, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)