At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 52 enrolled
Drug / intervention
Odevixibat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)
In Brief
A Phase 3 clinical trial evaluating Odevixibat and Placebo for Alagille Syndrome. Completed, enrolled 52 participants across 32 sites in 13 countries.
Detailed Summary
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlagille Syndrome
CountriesBelgium, Canada, France, Germany, Israel, Italy, Malaysia, Netherlands, New Zealand, Poland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartMar 2021
Primary CompletionSep 2022
TodayJul 2026
First PostedDec 19, 2020
Enrollment StartMar 19, 2021
Primary CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.5 years ago
Interventions
Odevixibatdrug
Odevixibat is a small molecule and selective inhibitor of IBAT.
Placebodrug
Placebo identical in appearance to experimental drug (odevixibat).