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 | EUCTR2014-005012-42-ES (EUCTR) | 18/12/2015 | 30/10/2015 | A Phase 3b clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cirrhosis. | A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis | Primary Biliary Cirrhosis MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;United States;Serbia;Estonia;Spain;Chile;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden |