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Clinical Trials/EUCTR2019-003807-37-HU
EUCTR2019-003807-37-HUActive, not recruitingPhase 1

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)

Albireo AB0 sites200 target enrollmentStarted: April 17, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Albireo AB
Enrollment
200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. A male or female patient with a clinical diagnosis of BA
  • •2. Age at Kasai HPE =90 days
  • •3. Eligible to start study treatment within 3 weeks post-Kasai HPE
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Patients with intractable ascites
  • •2. Ileal resection surgery
  • •3. ALT =10× upper limit of normal (ULN) at screening
  • •4. Patient on total parenteral nutrition at randomization
  • •5. Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
  • •6. Choledochal cystic disease

Investigators

Sponsor
Albireo AB

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