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Clinical Trial NCT04336722

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD)

  • ClinicalTrials.gov ID: NCT04336722
  • Not accepting healthy volunteers
  • UTSW Principal Investigator: AMAL AHMAD IBRAHIM AQUL

objective

Primary Objective The primary objective is to evaluate the efficacy of repeated once-daily doses of odevixibat versus placebo in children with biliary atresia (BA) post Kasai hepatoportoenterostomy(HPE) based on survival with native liver after 104 weeks of study treatment. Secondary Objectives • To evaluate the effect of odevixibat compared to placebo on the time to onset of sentinel events (defined as clinically significant ascites, bleeding gastroesophageal varices, thrombocytopenia [platelet count <150,000/μL], liver transplant, or death) within the 104-week treatment period • To evaluate the effect of odevixibat compared to placebo on total bilirubin after 13, 26, 52, and 104 weeks of study treatment • To evaluate the effect of odevixibat compared to placebo on serum bile acids after 13, 26, 52, and 104 weeks of study treatment • To assess the long-term safety and tolerability of repeated daily doses of odevixibat compared to placebo for 104 weeks in children with B[See protocol for complete text]

If you are interested in this clinical trial, please contact Claudia Sanchez Lucas on the Children’s Health Research Team.Call 214-489-0557Email