NCT04674761

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Albireo · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 35 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.

Conditions

• Alagille Syndrome

Interventions

Type	Name	Description
DRUG	Odevixibat	Odevixibat is a small molecule and selective inhibitor of IBAT.
DRUG	Placebo	Placebo identical in appearance to experimental drug (odevixibat).

Timeline

• Start date: 2021-03-19
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2020-12-19
• Last updated: 2023-11-02
• Results posted: 2023-11-02

Locations

32 sites across 13 countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Malaysia, Netherlands, New Zealand, Poland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study