clinical trial · NCT03566238
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Albireo·phase3·completed·n = 62
PFIC1PFIC2A4250 (odevixibat)Placebo
brief summary
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.
started
May 16, 2018
primary completion
Jul 27, 2020
completion
Jul 28, 2020
last updated
Nov 28, 2025
detailed description
Up to 50 sites in the following countries will take part in this study:
Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, Turkey, United Kingdom, United States, and Saudi Arabia
official title
A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol