297. アラジール症候群 Alagille syndrome Clinical trials / Disease details


臨床試験数 : 43 薬物数 : 19 - (DrugBank : 9) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 2

  
14 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000996-36-NL
(EUCTR)
04/03/202202/09/2021A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Netherlands;Germany;New Zealand
2EUCTR2021-000996-36-IT
(EUCTR)
09/11/202127/01/2022A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) - NA Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250-015
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
ALBIREO ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand
3NCT05035030
(ClinicalTrials.gov)
September 3, 202113/8/2021Long-term Safety and Efficacy of Odevixibat in Patients With Alagille SyndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)Alagille SyndromeDrug: OdevixibatAlbireoNULLEnrolling by invitationN/AN/AAll63Phase 3United States;France;Poland;United Kingdom
4EUCTR2020-004011-28-DE
(EUCTR)
21/07/202115/04/2021An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand
5EUCTR2020-004011-28-NL
(EUCTR)
08/06/202116/12/2020An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
6NCT04674761
(ClinicalTrials.gov)
March 19, 202110/12/2020Efficacy and Safety of Odevixibat in Patients With Alagille SyndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)Alagille SyndromeDrug: Odevixibat;Drug: PlaceboAlbireoNULLRecruitingN/AN/AAll63Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Malaysia;Netherlands;New Zealand;Poland;Turkey;United Kingdom
7EUCTR2020-004011-28-IT
(EUCTR)
24/02/202120/05/2021An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) - NA Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
ALBIREO ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;United States;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
8EUCTR2020-004011-28-FR
(EUCTR)
09/02/202125/11/2020An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 3United States;France;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
9EUCTR2021-000996-36-FR
(EUCTR)
25/06/2021A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLNAFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Germany;Netherlands;New Zealand
10EUCTR2021-000996-36-PL
(EUCTR)
01/09/2021A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLNAFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Malaysia;Belgium;Germany;Netherlands;New Zealand
11EUCTR2021-000996-36-DE
(EUCTR)
02/11/2021A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLNAFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Germany;Netherlands;New Zealand
12EUCTR2020-004011-28-BE
(EUCTR)
19/01/2021An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLNAFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand
13EUCTR2021-000996-36-BE
(EUCTR)
01/09/2021A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeAn Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLNAFemale: yes
Male: yes
60Phase 3United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand
14EUCTR2020-004011-28-PL
(EUCTR)
07/12/2020An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndromeA Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) Alagille Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Other descriptive name: A4250
Albireo ABNULLNAFemale: yes
Male: yes
60Phase 3United Kingdom;Italy;United States;France;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Germany