297. Alagille syndrome Clinical trials / Disease details
Clinical trials : 43 / Drugs : 19 - (DrugBank : 9) / Drug target genes : 2 - Drug target pathways : 2
Showing 1 to 10 of 43 diseases
| 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 A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrom ... | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients ... | 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] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | 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 United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Netherlands;G ... | ||
| 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 A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrom ... | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) - NA An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients ... | 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] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | 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 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: ... | 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 United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Nethe ... | ||
| 3 | NCT04729751 (ClinicalTrials.gov) | September 9, 2021 | 25/1/2021 | A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestat ... | Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of ... | Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Cholestatic Liver Disease | Drug: Maralixibat | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | N/A | 364 Days | All | 12 | Phase 2 | United States;Belgium;France;Poland;United Kingdom |
| 4 | 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) An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients ... | Alagille Syndrome | Drug: Odevixibat | Albireo | NULL | Enrolling by invitation | N/A | N/A | All | 63 | Phase 3 | United States;France;Poland;United Kingdom |
| 5 | 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) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | 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] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | 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 United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Nethe ... | ||
| 6 | 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) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | 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] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | 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 United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Ital ... | ||
| 7 | EUCTR2020-004628-40-FR (EUCTR) | 25/03/2021 | 16/12/2020 | Clinical study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome. Clinical study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants wi ... | Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome. - Maralixibat Infant Safety Evaluation (RISE). Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of ... | Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome. MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;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] Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Synd ... | Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product Name: Maralixibat (formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBAT CHLORIDE Product Name: Maralixibat(formely SHP625 or LUM001) INN or Proposed INN: MARALIXIBATCHLORIDE Product N ... | Mirum Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;Poland;Belgium;United Kingdom | ||
| 8 | 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) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | 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 United States;Belgium;Canada;France;Germany;Israel;Italy;Malaysia;Netherlands;New Zealand;Poland;Tur ... |
| 9 | 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 A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | 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] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | 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 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: ... | 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 France;United States;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Ital ... | ||
| 10 | 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) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | 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] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | 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 United States;France;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Ital ... |