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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    200
  • sponsor
    Albireo
Updated on 30 May 2022
Investigator
Albireo
Primary Contact
The Hospital for Sick Children (0.3 mi away) Contact
+70 other location

Summary

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.

Description

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

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

Eligibility

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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