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 | EUCTR2021-001389-39-DE (EUCTR) | 19/04/2022 | 01/10/2021 | A study to evaluate efficacy and safety of an investigational drug namedvolixibat in patients with itching caused by primary biliary cholangitis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluatethe Efficacy and Safety of Volixibat in the Treatment of CholestaticPruritus in Patients with Primary Biliary Cholangitis (VANTAGE) - VANTAGE | Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: volixibat INN or Proposed INN: volixibat potassium Other descriptive name: volixibat Product Name: volixibat INN or Proposed INN: volixibat potassium Other descriptive name: volixibat | Mirum Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | France;United States;Canada;Israel;Germany;United Kingdom;Italy | ||
| 2 | NCT05050136 (ClinicalTrials.gov) | September 22, 2021 | 9/9/2021 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis;PBC | Drug: Volixibat;Drug: Placebo | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 260 | Phase 2 | United States;France;Germany;Israel;United Kingdom |