RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Completed · Phase 3 · Has a placebo group
Conditions studied: Primary Biliary Cholangitis
In brief
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.
Key facts
- Study ID
- NCT04620733
- Run by
- Gilead Sciences
- People needed
- 193
- Starts
- 2021-04-21
- Expected to finish
- 2023-08-11
- Last updated by the study team
- 2024-09-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arkansas Diagnostic Center — Little Rock, Arkansas, United States
- Stanford University School of Medicine — Palo Alto, California, United States
- California Liver Research Institute — Pasadena, California, United States
- University of California, Davis Medical Center — Sacramento, California, United States
- California Pacific Medical Center - Sutter Pacific Medical Foundation — San Francisco, California, United States
- Covenant Metabolic Specialists, LLC — Fort Myers, Florida, United States
- Florida Research Institute — Lakewood Rch, Florida, United States
- Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States
- Covenant Research and Clinics, LLC — Sarasota, Florida, United States
- Digestive Healthcare of Georgia — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Chicago Hospitals — Chicago, Illinois, United States
- Tulane University Health Sciences Center — New Orleans, Louisiana, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Henry Ford Health System — Novi, Michigan, United States
- MNGI Digestive Health, P.A. — Maplewood, Minnesota, United States
- Southern Therapy and Advanced Research, LLC (STAR) — Jackson, Mississippi, United States
- Saint Louis University — St Louis, Missouri, United States
- NYU Langone Health / NYU Grossman School of Medicine — New York, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- The Institute for Liver Health DBA Arizona Liver Health — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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