Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)

PHASE2TerminatedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

November 4, 2015

Primary Completion Date

July 1, 2016

Study Completion Date

July 1, 2016

Conditions
Primary Biliary Cirrhosis (PBC)
Interventions
DRUG

Placebo Comparator

Placebo Capsule

DRUG

Experimental: Seladelpar 50 mg

Seladelpar 50 mg capsule

DRUG

Experimental: Seladelpar / MBX-8025 200 mg

Seladelpar 100 mg capsules

Trial Locations (49)

10016

NYU Langone Medical Center, New York

10029

Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center, New York

10117

Charite Universitatsmedizin Berlin - Campus Mitte, Berlin

10969

Leber- und Studienzentrum am Checkpoint, Berlin

11030

North Shore-Long Island Jewish Health System / Division of Gastroenterology, Manhasset

20099

Ifi-Studien und Projekte GmbH, A.d. Asklepios Klinik St. Georg, Hamburg

20246

Universitatsklinikum Hamburg-Eppendorf MARTINISTRASSE 52, Hamburg

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Bon Secours St. Mary's Hospital of Richmond, Newport News

24105

UKSH, Campus Kiel, Klinik fur Allgemeine Innere Medizin 1, Kiel

UKSH, Campus Kiel, Kiel

30308

Norman Gitlin, MD, Atlanta

30309

Digestive Helathcare of Georgia, Atlanta

30625

Med. Hochschule Hannover, Klinik fur Gastroenterologie, Hanover

32610

University of Florida, Gainesville

33136

University of Miami, Center for Liver Diseases, Miami

44623

Gastroenterologische Gemeinschaftspraxis Herne, Herne

45157

Universitatsklinikum Essen, Zentrum fur Innere Medizin, Essen

45249

Consultants for Clinical Research, Cincinnati

46202

Indiana University Hospital - Clinical Research Center, Indianapolis

48202

Henry Ford Health System, Detroit

49519

Gastroenterology Associates of Western Michigan, PLC, d.b.a. West Michigan Clinical Research, Wyoming

53127

Universitatsklinikum Bonn, Bonn

55131

Universitatsmedizin der Johannes Gutenberg - Universitat Mainz, Mainz

63110

St. Louis University School of Medicine, St Louis

64131

Kansas City Gastroenterology and Hepatology, Kansas City

68198

University of Nebraska Medical Center / The Nebraska Medical Center, Omaha

69120

Medizinische Universitatsklinik, Heidelberg

77030

CHI St. Luke's Health Baylor College of Medicine Medical Center - Advanced Liver Therapies, Houston

78215

American Research Corporation at Texas Liver Institute, San Antonio

78233

Pinnacle Clinical Research, Live Oak

85054

Mayo Clinic of Arizona, Phoenix

91054

University Hospital Erlangen, Erlangen

95817

University of California, Davis Medical Center, Sacramento

T2N 4Z6

University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary

M5G 2C4

Toronto General Hospital, Toronto

01307

Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden

04103

Universitatsklinikum Leipzig AOR, Leipzig

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza w Bydgoszczy, Bydgoszcz

31-531

SPZOZ Szpital Uniwersytecki w Krakowie, Krakow

02-781

Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie, Warsaw

40-752

SP CSK im. Prof. K. Gibinskiego SUM w Katowicach, Katowice

41-400

ID Clinic Arkadiusz Pisula, Mysłowice

PL6 8DH

Derriford Hospital, Plymouth

B15 2GW

University Hospital Birmingham NHS Foundation Trust, Birmingham

CB2 0QQ

Addenbrooke Hospital, Cambridge

HU3 2jZ

Hull and East Yorkshire NHS Trust, Hull

NE1 4LP

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY