Title: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Associated condition: Primary Biliary Cholangitis (PBC)
Status: Currently enrolling
Brief summary: 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.
Primary objectives:
Composite endpoint of ALP and total bilirubin [ Time Frame: 12 months ]
- ALP < 1.67× ULN,
- ≥ 15% decrease in ALP, and
- Total bilirubin ≤1.0× ULN
Estimated length of study: It is estimated that the study be fully completed by March 2023. Patient time in study approximately 12 months.
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.
