Last updated on August 2017

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)


Brief description of study

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Detailed Study Description

Primary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment Secondary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment To evaluate the pharmacokinetics (PK) of MBX-8025 Exploratory: To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs

Clinical Study Identifier: NCT02955602

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Tarek Hassanein, MD

Southern California Research Center
Coronado, CA United States
  Connect »

Christopher Bowlus, MD

University of California, Davis Medical Center
Sacramento, CA United States
  Connect »

Cynthia Levy, MD

University of Miami - Center for Liver Diseases
Miami, FL United States
  Connect »

Norman Gitlin, MD

Atlanta Gastroenterology Associates, LLC
Atlanta, GA United States
  Connect »

Michael R Galambos, MD

Digestive Healthcare of Georgia
Atlanta, GA United States
  Connect »

Paul Thuluvath, MD

Mercy Medical Center
Baltimore, MD United States
  Connect »

Stuart C Gordon, MD

Henry Ford Health System
Novi, MI United States
  Connect »

Brian Borg, MD

University of Mississippi Medical Center
Jackson, MS United States
  Connect »

Bruce Bacon, MD

Saint Louis University, Gastroenterology & Hepatology
Saint Louis, MO United States
  Connect »

David Bernstein, MD

Northwell Health - Center for Liver Disease and Transplantation
Manhasset, NY United States
  Connect »

Carmen Stancia, MD

NYU Langone Medical Center
New York, NY United States
  Connect »

Joseph Odin, MD

The Mount Sinai Medical Center
New York, NY United States
  Connect »

Marlyn Mayo, MD

UT Southwestern Medical Center Investigation Drug Service
Dallas, TX United States
  Connect »

John M Vierling, MD

Baylor College of Medicine
Houston, TX United States
  Connect »

Stephen A Harrison, MD

Gastroenterology Consultants of SA
Live Oak, TX United States
  Connect »

Mitchell Shiffman, MD

Bon Secours St. Mary's Immaculate Hospital
Newport News, VA United States
  Connect »

Mark Swain, M.D.

University of Calgary Liver Unit
Calgary, AB Canada
  Connect »

Hemant Shah, MD

Toronto Centre for Liver Disease
Toronto, ON Canada
  Connect »

Yvonne Dorffel, MD

Outpatient Clinic of Internal Medicine
Berlin, Germany
  Connect »

Andreas Kremer, MD

University Hospital Erlangen
Erlangen, Germany
  Connect »

Peter Buggisch, MD

Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Hamburg, Germany
  Connect »

Michael Manns, MD

Center of Internal Medicine - Medical School of Hannover
Hannover, Germany
  Connect »

Marcus Worns, MD

University Medical Centre of the Johannes Guttenberg-University
Mainz, Germany
  Connect »

Christoph Berg, MD

Medizinische Universitatsklinik Tubingen
Tubingen, Germany
  Connect »

Gideon Hirschfield, MD

University Hospitals Birmingham
Birmingham, United Kingdom
  Connect »

George Mells, MD

Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
  Connect »

Lynsey Corless, MD

Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom
  Connect »

Douglas Thorburn, MD

Royal Free London NHS Foundation Trust
London, United Kingdom
  Connect »

David Sheridan, MD

Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
  Connect »

Richard Aspinall, MD

Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
  Connect »