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
| 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 | EUCTR2021-000996-36-NL (EUCTR) | 04/03/2022 | 02/09/2021 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | An 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Netherlands;Germany;New Zealand | ||
| 2 | EUCTR2021-000996-36-IT (EUCTR) | 09/11/2021 | 27/01/2022 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | An 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand | ||
| 3 | NCT05035030 (ClinicalTrials.gov) | September 3, 2021 | 13/8/2021 | Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT) | Alagille Syndrome | Drug: Odevixibat | Albireo | NULL | Enrolling by invitation | N/A | N/A | All | 63 | Phase 3 | United States;France;Poland;United Kingdom |
| 4 | EUCTR2020-004011-28-DE (EUCTR) | 21/07/2021 | 15/04/2021 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand | ||
| 5 | EUCTR2020-004011-28-NL (EUCTR) | 08/06/2021 | 16/12/2020 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy | ||
| 6 | NCT04674761 (ClinicalTrials.gov) | March 19, 2021 | 10/12/2020 | Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT) | Alagille Syndrome | Drug: Odevixibat;Drug: Placebo | Albireo | NULL | Recruiting | N/A | N/A | All | 63 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Malaysia;Netherlands;New Zealand;Poland;Turkey;United Kingdom |
| 7 | EUCTR2020-004011-28-IT (EUCTR) | 24/02/2021 | 20/05/2021 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2020-004011-28-FR (EUCTR) | 09/02/2021 | 25/11/2020 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 3 | United States;France;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 9 | NCT03082937 (ClinicalTrials.gov) | January 31, 2017 | 27/2/2017 | An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects | An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis | Drug: 3 mg [14C]-A4250 capsule | Albireo | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 10 | NCT02963077 (ClinicalTrials.gov) | July 2013 | 1/11/2016 | A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 | A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |
| 11 | EUCTR2021-000996-36-BE (EUCTR) | 01/09/2021 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | An 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 AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand | |||
| 12 | EUCTR2021-000996-36-FR (EUCTR) | 25/06/2021 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | An 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 AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Germany;Netherlands;New Zealand | |||
| 13 | EUCTR2021-000996-36-DE (EUCTR) | 02/11/2021 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | An 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 AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Germany;Netherlands;New Zealand | |||
| 14 | EUCTR2020-004011-28-PL (EUCTR) | 07/12/2020 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A 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 AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United Kingdom;Italy;United States;France;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Germany | |||
| 15 | EUCTR2021-000996-36-PL (EUCTR) | 01/09/2021 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | An 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 AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Malaysia;Belgium;Germany;Netherlands;New Zealand | |||
| 16 | EUCTR2020-004011-28-BE (EUCTR) | 19/01/2021 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A 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 AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand |