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

  
3 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003158-10-GR
(EUCTR)
19/12/202225/10/2022Linerixibat Long-term Safety and Tolerability Study (LLSAT)Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by 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: linerixibat (GSK2330672) 40 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
305Phase 3United States;Czechia;Greece;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;China;Japan
2EUCTR2019-003158-10-BE
(EUCTR)
31/01/202223/11/2021Linerixibat Long-term Safety and Tolerability Study (LLSAT)Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by 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: linerixibat (GSK2330672) 40 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
305Phase 3United States;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;China;Japan
3EUCTR2019-003158-10-PL
(EUCTR)
22/06/202027/03/2020Linerixibat Long-term Safety and Tolerability Study (LLSAT)Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
MedDRA version: 21.1;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: linerixibat (GSK2330672) 45mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
Product Name: linerixibat (GSK2330672) 40 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
Product Name: linerixibat (GSK2330672) 45 mg
Product Code: GSK2330672
INN or Proposed INN: Linerixibat
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3France;United States;Canada;Poland;Italy;United Kingdom;Japan