EUCTR2019-003807-37-ITActive, 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) - BOLD
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ALBIREO AB
- Enrollment
- 200
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
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