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A4250

DRUG5 trials

Sponsors

Ipsen Pharma, Sahlgrenska University Hospital, Albireo

Conditions

Alagille SyndromeBiliary AtresiaBiliary Cirrhosis, PrimaryHealthy VolunteersOrphan Cholestatic Liver DiseasesPediatric CholestasisPrimary Biliary CirrhosisProgressive Familial Intrahepatic Cholestasis

Phase 1

A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
CompletedNCT02963077
AlbireoAlagille Syndrome, Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis +1
Start: 2013-07-31End: 2014-05-31Updated: 2024-03-07
Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions
CompletedNCT03608319
AlbireoHealthy Volunteers
Start: 2018-07-05End: 2018-08-18Updated: 2024-03-07

Phase 2

IBAT Inhibitor A4250 for Cholestatic Pruritus
TerminatedNCT02360852
Sahlgrenska University HospitalBiliary Cirrhosis, Primary
Start: 2015-01-31End: 2016-10-31Updated: 2017-02-23
A4250, an IBAT Inhibitor in Pediatric Cholestasis
CompletedNCT02630875
AlbireoPediatric Cholestasis
Start: 2015-08-31End: 2017-03-17Updated: 2024-03-07

Phase 3

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia (BOLD-EXT)
RecruitingCTIS2022-501090-39-00
Ipsen PharmaBiliary Atresia
Start: 2022-12-14Target: 57Updated: 2025-12-12