Title: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended 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)
Associated condition: Primary Biliary Cholangitis
Status: Currently enrolling
Brief summary: Evaluate the effect of seladelpar treatment over 52 weeks compared to placebo on normalization of alkaline phosphatase (ALP) in PBC subjects with an ALP value greater than upper limit of normal (ULN) but less than 1.67×ULN
Primary objectives:
Subject response defined as an ALP ≤ULN at Week 52
Estimated length of study: It is estimated that the study be fully completed by August, 2025.
For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.
