Bylvay (odevixibat) / Albireo, Ipsen 
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7 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Bylvay (odevixibat) / Ipsen
ASSERT, NCT04674761 / 2020-004011-28: Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

Completed
3
52
Europe, Canada, US, RoW
Odevixibat, A4250, Placebo
Albireo
Alagille Syndrome
09/22
09/22
ASSERT-EXT, NCT05035030 / 2021-000996-36: Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

Recruiting
3
70
Europe, US, RoW
Odevixibat, A4250
Albireo, an Ipsen Company
Alagille Syndrome
10/26
04/27
PEDFIC 2, NCT03659916 / 2017-002325-38: Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

Active, not recruiting
3
116
Europe, Canada, US, RoW
A4250 (odevixibat)
Albireo, an Ipsen Company
Progressive Familial Intrahepatic Cholestasis
02/24
03/25
BOLD-EXT, NCT05426733: An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

Enrolling by invitation
3
180
Europe, Canada, US, RoW
Odevixibat, A4250
Albireo, an Ipsen Company
Biliary Atresia
07/28
08/28
BOLD, NCT04336722 / 2019-003807-37: Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE

Active, not recruiting
3
254
Europe, Canada, US, RoW
Odevixibat, Placebo
Albireo, an Ipsen Company
Biliary Atresia
06/26
07/26
2014-004070-42: Study to Demonstrate the Efficacy and Safety of A4250 in Patients withPrimary Biliary Cirrhosis and Cholestatic Pruritus

Ongoing
2
12
Europe
A4250,
Sahlgrenska Academy, Swedish Research Council
Primary biliary cirrhosis complicated by cholestatic pruritus.
 
 
NCT06258902: Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

Recruiting
N/A
20
US
Ipsen
Pregnancy Related
09/31
09/32

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