Oca (int-747) (DrugBank: -)
1 disease| 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)］ | 6 |
| 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 | 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 | |||
| 2 | EUCTR2011-004728-36-PL (EUCTR) | 30/05/2012 | 20/04/2012 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis 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] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Austria;Switzerland;United Kingdom;Italy;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 3 | EUCTR2011-004728-36-SE (EUCTR) | 16/04/2012 | 16/02/2012 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis 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] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 4 | EUCTR2011-004728-36-BE (EUCTR) | 30/03/2012 | 13/02/2012 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis 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] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 5 | EUCTR2011-004728-36-DE (EUCTR) | 22/03/2012 | 16/02/2012 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis 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] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 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 |
| 6 | EUCTR2011-004728-36-GB (EUCTR) | 09/03/2012 | 23/02/2012 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden |