Status and phase
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About
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.
Full description
Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
254 participants in 2 patient groups, including a placebo group
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Central trial contact
Ipsen Clinical Study Enquiries
Data sourced from clinicaltrials.gov
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