Volixibat (formely SHP626, LUM002 or SAR548304B) ( DrugBank: Volixibat )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
94原発性硬化性胆管炎1

94. 原発性硬化性胆管炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003027-41-DE
(EUCTR)
17/11/202117/06/2021A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Canada;Israel;Germany;United Kingdom