119
Participants
Start Date
November 28, 2016
Primary Completion Date
September 7, 2018
Study Completion Date
July 8, 2019
MBX-8025 2 mg Capsule
"Initial 8-week treatment:~• MBX-8025 2 mg~Extension:~The 2 mg group will be started after safety and efficacy review of the 5 mg and the 10 mg groups has been completed.~Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons."
MBX-8025 5 mg Capsule
"Initial 8-week treatment:~• MBX-8025 5 mg~Extension:~Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons."
MBX-8025 10 mg Capsule
"Initial 8-week treatment:~• MBX-8025 10 mg~Extension:~Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons."
NYU Langone Medical Center, New York
The Mount Sinai Medical Center, New York
Outpatient Clinic of Internal Medicine, Berlin
Northwell Health - Center for Liver Disease and Transplantation, Manhasset
Northest Clinical Research Center, LLC., Bethlehem
Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg, Hamburg
Mercy Medical Center, Baltimore
Bon Secours St. Mary's Immaculate Hospital, Newport News
Atlanta Gastroenterology Associates, LLC, Atlanta
Digestive Healthcare of Georgia, Atlanta
Center of Internal Medicine - Medical School of Hannover, Hanover
University of Miami - Center for Liver Diseases, Miami
Florida Research Institute, Lakewood Rch
Universitatsklinikum Giessen und Marburg GmbH, Marburg
University of Mississippi Medical Center, Jackson
Henry Ford Health System, Novi
University Medical Centre of the Johannes Guttenberg-University, Mainz
Northwestern University, Chicago
Saint Louis University, Gastroenterology & Hepatology, St Louis
Medizinische Universitatsklinik Tubingen, Tübingen
UT Southwestern Medical Center Investigation Drug Service, Dallas
Baylor College of Medicine, Houston
Gastroenterology Consultants of SA, Live Oak
Institute for Liver Health, Chandler
University Hospital Erlangen, Erlangen
Southern California Research Center, Coronado
Ventura Clinical Trials, Ventura
Standford University Medicine, Palo Alto
University of California, Davis Medical Center, Sacramento
University of Washington, Seattle
University of Calgary Liver Unit, Calgary
Toronto Centre for Liver Disease, Toronto
University Hospitals Birmingham, Birmingham
Cambridge University Hospitals NHS Foundation Trust, Cambridge
Hull and East Yorkshire Hospitals NHS Trust, Hull
Royal Free London NHS Foundation Trust, London
Plymouth Hospitals NHS Trust, Plymouth
Portsmouth Hospitals NHS Trust, Portsmouth
Lead Sponsor
Gilead Sciences
INDUSTRY