Title: Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (ELATIVE)
Associated condition: Primary Biliary Cholangitis (PBC)
Status: Currently enrolling
Brief summary: The main objective of the study is to evaluate the effect of daily oral administration of 80mg elafibranor on cholestasis (impairment of bile formation and/or bile accumulation) in patients with PBC and inadequate response or intolerance to Ursodeoxycholic Acid (UCDA)
Primary objectives:
Effect of elafibranor (80 mg/day) on cholestasis [ Time Frame: From baseline to 52 weeks of treatment ]
- Response to treatment defined as Alkaline phosphatase (ALP) < 1.67 x Upper Limit Normal (ULN) and Total Bilirubin (TB) ≤ ULN and ALP decrease ≥ 15 percent
Estimated length of study: It is estimated that the study be fully completed by December 2028. Patient time in study approximately 12 months plus a long term extension option of 4-5 years.
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.
