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

  
2 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2021-000007-21-GR
(EUCTR)
28/06/202211/05/2022Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC). - PH3a,linerixibat vsPBO,efficacy&safety,itch study for the treatment of cholestatic pruritus in PBC Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).
MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK2330672/linerixibat 40 mg
Product Code: GSK2330672/linerixibat 40 mg
INN or Proposed INN: Linerixibat
Other descriptive name: 3-({[(3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl]methyl}amino)pentanedioic acid
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Czechia;Greece;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;China;Japan
2EUCTR2021-000007-21-CZ
(EUCTR)
23/06/202212/04/2022Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC). - PH3a,linerixibat vsPBO,efficacy&safety,itch study for the treatment of cholestatic pruritus in PBC Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).
MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GSK2330672/linerixibat 40 mg
Product Code: GSK2330672/linerixibat 40 mg
INN or Proposed INN: Linerixibat
Other descriptive name: 3-({[(3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl]methyl}amino)pentanedioic acid
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Czechia;Greece;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;China;Japan