Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
Completed · Phase 3 · Has a placebo group
Conditions studied: Primary Biliary Cholangitis
In brief
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA). The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.
Key facts
- Study ID
- NCT06060665
- Run by
- Gilead Sciences
- People needed
- 96
- Starts
- 2023-09-05
- Expected to finish
- 2026-05-06
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health — Chandler, Arizona, United States
- California Liver Research Institute — Pasadena, California, United States
- University of California (UC) Davis Medical Center — Sacramento, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- University of Colorado Denver - School of Medicine - Anschutz Medical Campus — Aurora, Colorado, United States
- South Denver Gastroenterology — Englewood, Colorado, United States
- Florida Research Institute — Lakewood Rch, Florida, United States
- University of Miami - Schiff Center for Liver Diseases — Miami, Florida, United States
- Gastro Health Research — Miami, Florida, United States
- Covenant Metabolic Specialists, LLC — Sarasota, Florida, United States
- Covenant Metabolic Specialists, LLC — Tampa, Florida, United States
- Digestive Healthcare of Georgia — Atlanta, Georgia, United States
- Northwestern Medicine Clinical Research Unit (CRU) — Chicago, Illinois, United States
- Tulane University Medical Center — New Orleans, Louisiana, United States
- Louisiana Research Center, LLC — Shreveport, Louisiana, United States
- Mercy Medical Center - Baltimore, Maryland — 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
- University of Minnesota — Minneapolis, Minnesota, United States
- Kansas City Research Institute — Kansas City, Missouri, United States
- New-York-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States
- Northwell Health Center for Liver Disease and Transplantation — Manhasset, New York, United States
- New York University (NYU) Langone Medical Center — New York, New York, United States
- Weill Cornell Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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