93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
| 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 | EUCTR2011-004728-36-IT (EUCTR) | 13/03/2012 | 05/03/2012 | 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 Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis - A study of OCA in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 14.1;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) INN or Proposed INN: Acido Obeticolico Other descriptive name: Obeticholic Acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Acido Obeticolico Other descriptive name: Obeticholic Acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Acido Obeticolico Other descriptive name: Obeticholic Acid | INTERCEPT PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden |