265
Participants
Start Date
October 1, 2018
Primary Completion Date
February 16, 2020
Study Completion Date
February 16, 2020
seladelpar 5-10 mg
Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study
seladelpar 10 mg
Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study
Placebo
One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily
Budai Hepatológiai Centrum, Budapest
The Canberra Hospital, Garran
UZ Antwerpen, Edegem
UZ Leuven, Leuven
Royal Melbourne Hospital, Parkville
St Vincents Hospital Melbourne, Fitzroy
Waikato Hospital, Hamilton
Royal Brisbane & Women's Hospital, Herston
Debreceni Egyetem Klinikai Kozpont, Debrecen
Klinikum Wels-Grieskirchen GmbH, Wels
Salzburger Landeskliniken, Salzburg
Royal Perth Hospital, Perth
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár
Christchurch Hospital, Christchurch
LKH-Universitätsklinikum Klinikum Graz, Graz
UZ Gent, Ghent
Dunedin Hospital, Dunedin
Concorde Medical Group, New York
NYU Langone Health, New York
Icahn School of Medicine at Mount Sinai, New York
Center for Liver Disease and Transplantation, New York
Charité - Universitätsmedizin Berlin, Berlin
Clinical Hospital Centar Zvezdara, Belgrade
KBC Zemun, Belgrade
Seoul National University Bundang Hospital, Seongnam-si
University of Rochester Medical Center, Rochester
University of Pittsburgh Medical Center, Pittsburgh
Penn State Milton S Hershey Medical Center, Hershey
Northeast Clinical Research Center, LLC, Bethlehem
ASST di Monza - Azienda Ospedaliera San Gerardo, Rozzano
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo, Milan
ifi-Institute for Interdisciplinary Medicine, Hamburg
The Galilli Medical Center, Nahariya
Bon Secours Richmond Community Hospital, Richmond
Mary Immaculate Hospital, Newport News
Gastroenterologisch Hepatologisches Zentrum Kiel, Kiel
University General Hospital of Patras, Pátrai
Duke University Medical Center, Durham
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario La Paz, Madrid
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda
Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A., Asheville
Hospital Universitario Virgen de la Victoria, Málaga
Digestive Healthcare of Georgia, Atlanta
Carmel Medical Center, Haifa
Rambam Health Corporation, Haifa
Schiff Center for Liver Diseases University of Miami, Miami
Excel Medical Clinical Trials, LLC, Boca Raton
Tampa General Medical Group, Tampa
Florida Reserach Institute, Lakewood Rch
Azienda Ospedaliera Di Padova, Padua
Vanderbilt University Medical Center, Nashville
GIA Clinical Trials, LLC, Knoxville
CHU de GRENOBLE, Grenoble
Hillel Yaffe Medical Center, Hadera
Gastro One, Germantown
Digestive Health Specialists PA, Tupelo
Southern Therapy and Advance Research (STAR) LLC, Jackson
Hospital Universitario Virgen del Rocio, Seville
University General Hospital of Larissa, Larissa
Ospedale Civile di Baggiovara, Modena
Centro de Diabetes y Obesidad Graber, Pachuca
UH Cleveland Medical Center, Cleveland
Gastroenterologische Gemeinschaftspraxis Herne, Herne
Hospital Clinico Universitario de Valencia, Valencia
Hospital Universitari i Politecnic La Fe de Valencia, Valencia
Indianapolis Gastroenterology Research Foundation, Indianapolis
Henry Ford Health System, Novi
Pusan National University Hospital, Busan
Azienda Ospedaliera Universitaria Careggi, Florence
Uniklinik Köln, Cologne
Consultorio de la Doctora Maria Sarai Gonzalez Huezo, Metepec
Chaim Sheba Medical Center, Ramat Gan
Minnesota Gastroenterlogy, P.A., Maplewood
University of Minnesota Medical Center, Fairview, Minneapolis
University of Chicago Medical Center, Chicago
Kansas City Research Institute, Kansas City
Tel Aviv Sourasky Medical Center, Tel Aviv
University of Kansas Hospital, Kansas City
Tulane University School of Medicine, New Orleans
University General Hospital of Heraklion, Heraklion
Universitätsklinikum Tübingen, Tübingen
Hôpital Saint Antoine, Paris
Liver Institute at Methodist Dallas, Dallas
University of Texas Southwestern Medical Center, Dallas
Kaplan Medical Center, Rehovot
Texas Digestive Disease Consultants, Fort Worth
American Research Corporation, Houston
Baylor College of Medicine, Houston
American Research Corporation at Texas Liver Institute, San Antonio
Pinnacle Clinical Research, San Antonio
Univeristy of Colorado Denver and Hospital, Aurora
Intermountain Medical Center, Murray
Mayo Clinic Arizona - PPDS, Phoenix
Institute for Liver Health, Chandler
The Institute for Liver Health-Tucson, Tucson
Cedars Sinai Medical Center, Los Angeles
Universitätsklinikum Erlangen, Erlangen
Hadassah Medical Center, Jerusalem
Hôpital Jean Verdier, Bondy
Stanford University School of Medicine, Redwood City
California Pacific Medical Center, San Francisco
University of California Davis Medical Center, Sacramento
Swedish Medical Center, Seattle
Peoples Friendship University of Russia, Moscow
City Hospital #31, Saint Petersburg
Pius Brinzeu Emergency Clinical County Hospital, Timișoara
Ulyanovsk Regional Clinical Hospital, Ulyanovsk
Centro Clinico Mediterraneo, La Serena
Centro de Investigaciones Clínicas Vina del Mar, Viña del Mar
Pontificia Universidad Catolica de Chile, Santiago
Yale School of Medicine Digestive Diseases, Internal Medicine, New Haven
Beth Israel Deaconess Medical Center, Boston
Massachusetts General Hospital, Boston
Hospital Universitario Austral, Pilar
Fundación Sanatorio Güemes, Buenos Aires
Hospital Provincial Del Centenario, Rosario
DIM Clínica Privada, Ramos Mejía
Medizinische Universitat Wien, Vienna
University of Calgary Medicine, Calgary
University of Manitoba, Winnipeg
University Health Network, Toronto
Toronto Digestive Disease Associates Inc, Vaughan
McGill University Health Centre (MUHC), Montreal
Universitatsklinikum Leipzig, Leipzig
Consultorio Medico - Distrito Federal, Mexico City
Radboud Universitair Medisch Centrum, Nijmegen
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy, Bydgoszcz
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice
Wojewodzki Szpital Zespolony w Kielcach, Kielce
SP ZOZ Szpital Uniwersytecki w Krakowie, Krakow
ID Clinic, Mysłowice
Colentina Clinical Hospital, Bucharest
Fundeni Clinical Institute, Bucharest
Sana Monitoring SRL, Bucharest
Severance Hospital Yonsei University Health System, Seoul
Hospital Universitario Germans Trias i Pujol, Barcelona
Kyungpook National University Hospital, Daegu
Seoul National University Hospital, Seoul
Inje University Ilsan Paik Hospital, Seoul
Gangnam Severance Hospital, Yonsei University Health System, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Hospital Universitario Vall d'Hebrón - PPDS, Barcelona
Hospital Clinic de Barcelona, Barcelona
Queen Alexandra Hospital, Portsmouth
University Hospital Birmingham, Birmingham
Hull and East Yorkshire Hospitals NHS Trust, Hull
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London
Royal Free London NHS Foundation Trust, London
Kings College Hospital, London
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Newcastle
University of Nottingham, Nottingham
Plymouth Hospitals NHS Trust, Plymouth
Singleton Hospital, Swansea
Lead Sponsor
Gilead Sciences
INDUSTRY