OCA 1.5mg ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
296胆道閉鎖症7

296. 胆道閉鎖症


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
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2014-004693-42-FR
(EUCTR)
25/04/202207/01/2022A 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 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) 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]
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
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2France;Finland;Poland;Belgium;Netherlands;Germany;United Kingdom
2EUCTR2014-004693-42-FI
(EUCTR)
02/11/201820/07/2018A 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 Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia 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]
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
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 2United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy
3EUCTR2014-004693-42-NL
(EUCTR)
05/01/201609/09/2015A 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 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 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]
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
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60United States;Canada;Germany;Netherlands;United Kingdom
4EUCTR2014-004693-42-DE
(EUCTR)
06/11/201501/06/2015A 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 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 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]
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
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy
5EUCTR2014-004693-42-BE
(EUCTR)
27/08/201526/10/2015A 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 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) 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]
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
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2France;Finland;Poland;Belgium;Netherlands;Germany;United Kingdom
6NCT05321524
(ClinicalTrials.gov)
July 1, 201518/3/2022Obeticholic Acid in Pediatric Subjects With Biliary AtresiaA 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 AtresiaBiliary AtresiaDrug: OCA 0.1mg;Drug: OCA 1.5mg;Drug: OCA 5mgIntercept PharmaceuticalsNULLActive, not recruiting2 Years17 YearsAll32Phase 2Belgium;France;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
7EUCTR2014-004693-42-GB
(EUCTR)
29/06/201523/12/2014A 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 Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia 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]
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
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Finland;Belgium;Netherlands;Germany;Italy;United Kingdom