ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Who is this study for? Patients with Primary Biliary Cirrhosis
What treatments are being studied? Seladelpar
Status: Active_not_recruiting
Location: See all (107) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Must have given written informed consent (signed and dated)
• Participated in a PBC study with seladelpar
• 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 subjects 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
Locations
United States
Arkansas
Arkansas Diagnostic Center
Little Rock
California
Stanford University School of Medicine
Palo Alto
California Liver Research Institute
Pasadena
University of California Davis Medical Center
Sacramento
California Pacific Medical Center
San Francisco
Colorado
University of Colorado - Denver - PPDS
Aurora
Connecticut
Yale University School of Medicine
New Haven
Florida
Covenant Research Fort Myers
Fort Myers
Florida Digestive Health Specialist
Lakewood Rch
University of Miami Miller School of Medicine
Miami
Covenant Research, LLC
Sarasota
Georgia
Digestive Healthcare of Georgia PC
Atlanta
Illinois
University of Chicago Hospitals
Chicago
Louisiana
East Jefferson General Hospital
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center - 330 Brookline Ave
Boston
Massachusetts General Hospital
Boston
Maryland
Mercy Medical Center (Baltimore)
Baltimore
Michigan
Henry Ford Health System
Novi
Minnesota
MNGI Digestive Health PA-Plymouth
Minneapolis
Missouri
Saint Louis University
St Louis
Mississippi
Southern Therapy and Advanced Research LLC
Jackson
North Carolina
Duke University Medical Center
Durham
New York
Icahn School of Medicine at Mount Sinai
New York
NYU Langone Medical Center
New York
Weill Cornell Medical College
New York
University of Rochester Medical Center - PPDS
Rochester
Pennsylvania
Northeast Clinical Research Center, LLC
Bethlehem
Penn State Health Milton S. Hershey Medical Center
Hershey
University of Pittsburgh Medical Center
Pittsburgh
Tennessee
Galen Medical Group
Chattanooga
Gastro One-8110 Walnut Run Rd
Cordova
Vanderbilt University Medical Center
Nashville
Texas
Liver Institute at Methodist Dallas
Dallas
University of Texas Southwestern Medical Center
Dallas
Baylor College of Medicine
Houston
Pinnacle Clinical Research, PLLC
San Antonio
The Texas Liver Institute - 607 Camden St
San Antonio
Virginia
Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond
Washington
Liver Institute Northwest, PLLC
Seattle
Other Locations
Argentina
CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278
Balvanera
Hospital Italiano de Buenos Aires
Buenos Aires
DIM Clínica Privada
El Palomar
Hospital Italiano de La Plata
La Plata
Australia
Royal Brisbane and Women's Hospital
Herston
The Alfred Hospital
Melbourne
Royal Melbourne Hospital
Parkville
Austria
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels
Belgium
UZ Gent
Ghent
UZ Leuven
Leuven
Canada
University of Calgary Medicine
Calgary
Toronto General Hospital
Toronto
Chile
Centro Clinico Mediterraneo
La Serena
France
Hospices Civils de Lyon - Hôpital de La Croix Rousse
Lyon
AP-HP - Hôpital Saint Antoine
Paris
Germany
Charité - Universitätsmedizin Berlin
Berlin
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen
ifi-Institute for Interdisciplinary Medicine
Hamburg
Gastroenterologische Gemeinschaftspraxis Herne
Herne
Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134
Kiel
Universitätsklinikum Tübingen
Tübingen
Greece
University General Hospital of Larissa
Larissa
Hungary
Semmelweis Egyetem
Budapest
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár
Israel
Carmel Medical Center
Haifa
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv
The Chaim Sheba Medical Center - PPDS
Tel Aviv
Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2
Palermo
Fondazione IRCCS San Gerardo dei Tintori
Rozzano
Mexico
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
Metepec
Consultorio Medico - Distrito Federal
Roma Norte
Netherlands
Radboud Universitair Medisch Centrum
Nijmegen
New Zealand
Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Poland
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
Katowice
ID Clinic Arkadiusz Pisula
Mysłowice
Republic of Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Inje University Busan Paik Hospital
Busan
Pusan National University Hospital
Busan
Kyungpook National University Hospital
Daegu
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul
Asan Medical Center
Songpa-gu
Romania
Fundeni Clinical Institute
Bucharest
Spain
Hospital Universitario Germans Trias i Pujol
Badalona
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
Hospital Universitario La Paz - PPDS
Horcajo De La Sierra
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Marques de Valdecilla
Santander
Switzerland
Universitätsspital Zürich
Zurich
Turkey
Gazi University Faculty of Medicine
Ankara
Ege Universitesi Tip Fakultesi Hastanesi
Bornova
Ankara Bilkent City Hospital
Çankaya
Marmara University Pendik Training and Research Hospital
Maltepe
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Topkapı
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham
Hull Royal Infirmary
Hull
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London
King's College Hospital
London
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
Queen's Medical Centre
Nottingham
Derriford Hospital
Plymouth
Queen Alexandra Hospital
Portsmouth
Time Frame
Start Date: 2017-12-12
Completion Date: 2028-11
Participants
Target number of participants: 500
Treatments
Experimental: Seladelpar 5 mg Capsules
Experimental: Seladelpar 10 mg Capsule
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences