GSK2330672 ( DrugBank: GSK-2330672 )


1 disease
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15

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
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
2EUCTR2021-000007-21-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
3EUCTR2021-000007-21-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
4EUCTR2019-003158-10-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
5EUCTR2021-000007-21-IT
(EUCTR)
24/06/202117/08/2021Global 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: 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
Product Code: [GSK2330672]
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-
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Germany;Netherlands;China;Japan
6EUCTR2019-003158-10-FR
(EUCTR)
26/01/202109/11/2020Linerixibat Long-term Safety and Tolerability StudyLong-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
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;France;Canada;Poland;United Kingdom;Japan
7EUCTR2019-003158-10-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
8EUCTR2019-003158-10-GB
(EUCTR)
04/06/202004/02/2020Linerixibat Long-term Safety and Tolerability StudyLong-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
GlaxoSmithKline Research & Development LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Poland;Japan;United Kingdom
9EUCTR2019-003158-10-IT
(EUCTR)
14/05/202002/09/2021Linerixibat Long-term Safety and Tolerability StudyLong-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: 21.1;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Linerixibat (GSK2330672) 45mg
Product Code: [GSK2330672]
INN or Proposed INN: Linerixibat
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3France;United States;Canada;Poland;United Kingdom;Japan;Italy
10EUCTR2016-002416-41-PL
(EUCTR)
14/11/201705/09/2017Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). Primary biliary cholangitis (PBC)
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.0;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;France;Canada;Spain;Poland;Australia;Netherlands;United Kingdom;Japan
11EUCTR2016-002416-41-IT
(EUCTR)
01/08/201715/12/2020Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitisA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). - Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cho Primary biliary cholangitis (PBC)
MedDRA version: 20.0;Level: PT;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;France;Canada;Poland;Spain;Australia;Netherlands;United Kingdom;Japan;Italy
12EUCTR2016-002416-41-GB
(EUCTR)
24/03/201719/01/2017Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). Primary biliary cholangitis (PBC)
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 20.0;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Poland;Spain;Australia;Netherlands;Japan;United Kingdom
13EUCTR2016-002416-41-ES
(EUCTR)
17/02/201709/12/2016Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER StudyA randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). Primary biliary cholangitis (PBC)
MedDRA version: 19.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
Product Name: GSK2330672
Product Code: GSK2330672
INN or Proposed INN: GSK2330672
Other descriptive name: GSK2330672
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;France;Canada;Poland;Spain;Australia;Netherlands;Italy;United Kingdom;Japan
14NCT02966834
(ClinicalTrials.gov)
January 11, 201715/11/2016Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary CholangitisA Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)CholestasisDrug: Placebo;Drug: GSK2330672GlaxoSmithKlineNULLCompleted18 Years80 YearsAll147Phase 2United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom
15NCT01899703
(ClinicalTrials.gov)
March 10, 20143/7/2013A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of PruritusA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of GSK2330672 Administration in Patients With Primary Biliary Cirrhosis (PBC) and Symptoms of PruritusCholestasis, IntrahepaticDrug: GSK2330672;Drug: Placebo;Drug: Ursodeoxycholic acidGlaxoSmithKlineNULLCompleted18 Years75 YearsAll22Phase 2United Kingdom