296. 胆道閉鎖症 Biliary atresia Clinical trials / Disease details
臨床試験数 : 71 / 薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60
Showing 1 to 7 of 7 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 |
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1 | EUCTR2014-004693-42-FR (EUCTR) | 25/04/2022 | 07/01/2022 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body including an optional long-term extension. A study to look at how the study drug Obeticholic Acid(OCA), when given as a single dose and multipl ... | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects with Biliary Atresia - ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE) A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Labe ... | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID Product Name: OCA1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Produ ... | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | France;Finland;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
2 | EUCTR2014-004693-42-FI (EUCTR) | 02/11/2018 | 20/07/2018 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. A study to look at how the study drug Obeticholic Acid(OCA), when given as a single dose and multipl ... | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Ob ... | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID Product Name: OCA1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Produ ... | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
3 | EUCTR2014-004693-42-NL (EUCTR) | 05/01/2016 | 09/09/2015 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. A study to look at how the study drug Obeticholic Acid(OCA), when given as a single dose and multipl ... | A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label Extension to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label ... | Biliary atresia MedDRA version: 18.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 18.0;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Biliary atresia MedDRA version: 18.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA5mg Prod ... | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | United States;Canada;Germany;Netherlands;United Kingdom | |||
4 | EUCTR2014-004693-42-DE (EUCTR) | 06/11/2015 | 01/06/2015 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. A study to look at how the study drug Obeticholic Acid(OCA), when given as a single dose and multipl ... | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia- P/0204/2019 A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Ob ... | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID Product Name: OCA1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Produ ... | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
5 | EUCTR2014-004693-42-BE (EUCTR) | 27/08/2015 | 26/10/2015 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body including an optional long-term extension. A study to look at how the study drug Obeticholic Acid(OCA), when given as a single dose and multipl ... | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects with Biliary Atresia - ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE) A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Labe ... | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID Product Name: OCA1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Produ ... | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | France;Finland;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
6 | NCT05321524 (ClinicalTrials.gov) | July 1, 2015 | 18/3/2022 | Obeticholic Acid in Pediatric Subjects With Biliary Atresia | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, With an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects With Biliary Atresia A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, With an Optional Open-Labe ... | Biliary Atresia | Drug: OCA 0.1mg;Drug: OCA 1.5mg;Drug: OCA 5mg | Intercept Pharmaceuticals | NULL | Active, not recruiting | 2 Years | 17 Years | All | 32 | Phase 2 | Belgium;France;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
7 | EUCTR2014-004693-42-GB (EUCTR) | 29/06/2015 | 23/12/2014 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. A study to look at how the study drug Obeticholic Acid(OCA), when given as a single dose and multipl ... | A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Ob ... | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID Product Name: OCA1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Produ ... | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;Italy;United Kingdom |