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Clinical Trial Summary

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)


Clinical Trial Description

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


Study Design


Related Conditions & MeSH terms


NCT number NCT05035030
Study type Interventional
Source Albireo
Contact Albireo
Phone +1 (857) 378-2035
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 2021
Completion date October 2023

See also
  Status Clinical Trial Phase
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Active, not recruiting NCT02922751 - FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)
Completed NCT00001642 - Positional Cloning of the Gene(s) Responsible for Alagille Syndrome N/A
Recruiting NCT04674761 - Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome Phase 3
Completed NCT02117713 - An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome Phase 2
Completed NCT02131623 - Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
Completed NCT02963077 - A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 Phase 1
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT03082937 - An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects Phase 1
Completed NCT02047318 - An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS) Phase 2
Completed NCT01903460 - Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome Phase 2
Completed NCT01515631 - Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review
Available NCT04530994 - A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)