94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| 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 | EUCTR2020-003027-41-DE (EUCTR) | 17/11/2021 | 17/06/2021 | A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing 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 Sclerosing Cholangitis (VISTAS) - VISTAS | Pruritus associated with Primary Sclerosing Cholangitis (PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Volixibat (formely SHP626, LUM002 or SAR548304B) INN or Proposed INN: Volixibat potassium Other descriptive name: VOLIXIBAT Product Name: Volixibat (formely SHP626, LUM002 or SAR548304B) 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 | 300 | Phase 2 | United States;Canada;Israel;Germany;United Kingdom | ||
| 2 | NCT04663308 (ClinicalTrials.gov) | December 18, 2020 | 17/11/2020 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) | 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 Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Volixibat;Drug: Placebo | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | 16 Years | N/A | All | 200 | Phase 2 | United States;Canada;Germany;Israel;United Kingdom |