Obeticholic acid (oca) (DrugBank: Obeticholic acid)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 5 |
| 265 | 脂肪萎縮症 | 0 |
| 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 | NCT03633227 (ClinicalTrials.gov) | June 22, 2018 | 8/4/2018 | Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment | A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment | Liver Cirrhosis, Biliary | Drug: Obeticholic Acid (OCA);Drug: Placebo | Intercept Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 85 Years | All | 50 | Phase 4 | United States;Argentina;Australia;Belgium;Brazil;Canada;Estonia;Germany;Hungary;Italy;Lithuania;Spain |
| 2 | EUCTR2016-002965-67-NL (EUCTR) | 07/07/2017 | 29/03/2017 | A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteers | An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE | Primary biliairy cholangitis (PBC)Non-alcoholic steatohepatitis (NASH) 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 (INT-747) Product Code: OCA (INT-747) | AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 3 | NCT02308111 (ClinicalTrials.gov) | December 2014 | 10/11/2014 | Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis | A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis | Liver Cirrhosis, Biliary | Drug: Obeticholic Acid (OCA);Drug: Placebo | Intercept Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 428 | Phase 4 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Former Serbia and Montenegro |
| 4 | NCT01865812 (ClinicalTrials.gov) | November 2013 | 23/5/2013 | Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis | A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: obeticholic acid (OCA) | Intercept Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | United States |
| 5 | NCT01473524 (ClinicalTrials.gov) | January 2012 | 14/11/2011 | Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis | A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Obeticholic Acid (OCA);Drug: Placebo | Intercept Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 217 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;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 |