338. 進行性家族性肝内胆汁うっ滞症 Progressive familial intrahepatic cholestasis Clinical trials / Disease details
臨床試験数 : 60 / 薬物数 : 26 - (DrugBank : 6) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 2
Showing 1 to 10 of 23 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 | NCT04483531 (ClinicalTrials.gov) | June 1, 2021 | 13/7/2020 | Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis | Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Access Program) Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Acce ... | Progressive Familial Intrahepatic Cholestasis | Drug: Odevixibat | Albireo | NULL | Approved for marketing | N/A | N/A | All | United States | ||
| 2 | EUCTR2017-002325-38-BE (EUCTR) | 11/02/2019 | 04/09/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 3 | EUCTR2017-002325-38-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 4 | EUCTR2017-002325-38-IT (EUCTR) | 09/11/2018 | 11/10/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 5 | EUCTR2017-002325-38-GB (EUCTR) | 02/11/2018 | 26/06/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Aus ... | ||
| 6 | EUCTR2017-002325-38-NL (EUCTR) | 31/10/2018 | 01/08/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 7 | EUCTR2017-002325-38-SE (EUCTR) | 30/10/2018 | 07/06/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250(1200 µg) Product Code ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 8 | NCT03659916 (ClinicalTrials.gov) | September 28, 2018 | 24/8/2018 | Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children With Pro ... | Progressive Familial Intrahepatic Cholestasis | Drug: A4250 (odevixibat) | Albireo | NULL | Active, not recruiting | 0 Months | 100 Years | All | 120 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;S ... |
| 9 | EUCTR2017-002338-21-BE (EUCTR) | 13/09/2018 | 30/03/2018 | A study to determine if A4250 is safe and can be used to treat children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine if A4250is safe and can be used to treat children with Progressive Familial Int ... | A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1) A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 10 | EUCTR2017-002325-38-FR (EUCTR) | 11/09/2018 | 07/06/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Aus ... |