DDrare: Database of Drug Development for Rare Diseases

Searched query = "Biliary atresia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = A4250; Bicarbonate Ringer's solution; Cefoperazone; Chloride; Corticosteroids; Cysteine; Desflurane; Desflurane anesthetics; Dexamethasone; Dimethyl fumarate; Eicosapentaenoic acid; Epadel; Filgrastim; Gold; Granulocyte Colony-Stimulating Factor; ICG Pulsion; ICG-Pulsion 25mg; Indocyanine green; Intravenous immunoglobulin (IVIG); Lactated Ringer; Lactobacillus casei rhamnosus (Lcr35); MARALIXIBAT CHLORIDE; Magnesium; Magnesium gluconate; Magnesium sulfate; Maralixibat; Meloxicam; Methylprednisolone; N-Acetyl cysteine; Neomycin; Normal saline; OBETICHOLIC ACID; OCA; OCA 0.1 mg; OCA 1.5mg; OCA 5mg; Obeticholic acid; Ocaliva; Odevixibat; Oral Vancomycin; Other Crystalloid; Pentoxifylline; Prednisolone; Propanolol; Propofol; Rifaximin; Rituximab; Rocuronium; Sevoflurane; Sevoflurane anesthetics; Sulfate; UDCA; Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation; VO4CX; Vancomycin; [A4250]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003807-37-IT (EUCTR)	10/09/2020	21/10/2020	This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE	A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) - BOLD	Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat	ALBIREO AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of

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Condition

Intervention

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Inclusion_
agemin

Inclusion_
agemax

Inclusion_
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EUCTR2019-003807-37-IT
(EUCTR)

10/09/2020

21/10/2020

This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) - BOLD

Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat

ALBIREO AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of