Volixibat ( DrugBank: Volixibat )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎2
94原発性硬化性胆管炎2

93. 原発性胆汁性胆管炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001389-39-DE
(EUCTR)
19/04/202201/10/2021A study to evaluate efficacy and safety of an investigational drug namedvolixibat in patients with itching caused by primary biliary cholangitisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2France;United States;Canada;Israel;Germany;United Kingdom;Italy
2NCT05050136
(ClinicalTrials.gov)
September 22, 20219/9/2021A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary 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 Biliary CholangitisPrimary Biliary Cholangitis;PBCDrug: Volixibat;Drug: PlaceboMirum Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll260Phase 2United States;France;Germany;Israel;United Kingdom

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
2NCT04663308
(ClinicalTrials.gov)
December 18, 202017/11/2020A 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 CholangitisPrimary Sclerosing CholangitisDrug: Volixibat;Drug: PlaceboMirum Pharmaceuticals, Inc.NULLRecruiting16 YearsN/AAll200Phase 2United States;Canada;Germany;Israel;United Kingdom