Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

  • End date
    Jun 30, 2024
  • participants needed
  • sponsor
Updated on 30 May 2022
Primary Contact
The Hospital for Sick Children (0.3 mi away) Contact
+70 other location


Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.


Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.

Condition Biliary Atresia
Treatment Placebo, Odevixibat
Clinical Study IdentifierNCT04336722
Last Modified on30 May 2022


Yes No Not Sure

Inclusion Criteria

A male or female patient with a clinical diagnosis of BA
Age at Kasai HPE ≤90 days
Eligible to start study treatment within 3 weeks post-Kasai HPE

Exclusion Criteria

Patients with intractable ascites
Ileal resection surgery
ALT ≥10× upper limit of normal (ULN) at screening
Patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization
Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
Choledochal cystic disease
INR >1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized)
Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
Weight <3.5kg at randomization
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