EICHORCondition: Primary Biliary Cholangitis · Sponsor: Gilead Sciences
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| 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 | — |
+ 33 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06060665