Oca (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 94 | 原発性硬化性胆管炎 | 2 |
| 296 | 胆道閉鎖症 | 5 |
| 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 | EUCTR2014-002205-38-IT (EUCTR) | 02/12/2015 | 12/02/2018 | A Study of Obeticholic Acid (OCA) in Patients with Primary Sclerosing Cholangitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis - AESOP (Assessment of Efficacy and Safety of OCA in PSC) | Primary Sclerosing Cholangitis MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1,5 mg Product Code: INT-747, OCA INN or Proposed INN: ACIDO OBETICOLICO Other descriptive name: ACIDO OBETICOLICO Product Name: OCA 5 mg Product Code: INT-747, OCA INN or Proposed INN: ACIDO OBETICOLICO Other descriptive name: ACIDO OBETICOLICO | INTERCEPT PHARMACEUTICALS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Italy | ||
| 2 | NCT02177136 (ClinicalTrials.gov) | February 9, 2015 | 26/6/2014 | Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis (PSC) | Drug: OCA;Drug: Placebo | Intercept Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 77 | Phase 2 | United States;Italy;Austria;Belgium;France;Germany;Netherlands;Norway;Sweden;United Kingdom |
| 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 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 2 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | United States;Canada;Germany;Netherlands;United Kingdom | |||
| 3 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | 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. | 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: 19.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 19.0;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 Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Canada;Belgium;Netherlands;Germany;United Kingdom | ||
| 5 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;Italy;United Kingdom |