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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-003158-10-GR (EUCTR) | 19/12/2022 | 25/10/2022 | Linerixibat 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 305 | Phase 3 | United States;Czechia;Greece;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;China;Japan | ||
| 2 | EUCTR2021-000007-21-GR (EUCTR) | 28/06/2022 | 11/05/2022 | Global 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Czechia;Greece;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;China;Japan | ||
| 3 | EUCTR2021-000007-21-CZ (EUCTR) | 23/06/2022 | 12/04/2022 | Global 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Czechia;Greece;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;China;Japan | ||
| 4 | EUCTR2019-003158-10-BE (EUCTR) | 31/01/2022 | 23/11/2021 | Linerixibat 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 305 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;China;Japan | ||
| 5 | EUCTR2019-003158-10-FR (EUCTR) | 26/01/2021 | 09/11/2020 | Linerixibat Long-term Safety and Tolerability Study | 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 | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United States;France;Canada;Poland;United Kingdom;Japan | ||
| 6 | EUCTR2019-003158-10-PL (EUCTR) | 22/06/2020 | 27/03/2020 | Linerixibat 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | France;United States;Canada;Poland;Italy;United Kingdom;Japan | ||
| 7 | EUCTR2019-003158-10-GB (EUCTR) | 04/06/2020 | 04/02/2020 | Linerixibat Long-term Safety and Tolerability Study | 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 | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Poland;Japan;United Kingdom | ||
| 8 | EUCTR2019-003158-10-IT (EUCTR) | 14/05/2020 | 02/09/2021 | Linerixibat Long-term Safety and Tolerability Study | 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: 21.1;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 DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | France;United States;Canada;Poland;United Kingdom;Japan;Italy | ||
| 9 | EUCTR2016-002416-41-PL (EUCTR) | 14/11/2017 | 05/09/2017 | Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER Study | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Canada;Spain;Poland;Australia;Netherlands;United Kingdom;Japan | ||
| 10 | EUCTR2016-002416-41-IT (EUCTR) | 01/08/2017 | 15/12/2020 | Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis | A 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 DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Canada;Poland;Spain;Australia;Netherlands;United Kingdom;Japan;Italy | ||
| 11 | EUCTR2016-002416-41-GB (EUCTR) | 24/03/2017 | 19/01/2017 | Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER Study | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Poland;Spain;Australia;Netherlands;Japan;United Kingdom | ||
| 12 | EUCTR2016-002416-41-ES (EUCTR) | 17/02/2017 | 09/12/2016 | Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER Study | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Canada;Poland;Spain;Australia;Netherlands;Italy;United Kingdom;Japan | ||
| 13 | NCT02966834 (ClinicalTrials.gov) | January 11, 2017 | 15/11/2016 | Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis | A 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) | Cholestasis | Drug: Placebo;Drug: GSK2330672 | GlaxoSmithKline | NULL | Completed | 18 Years | 80 Years | All | 147 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom |
| 14 | NCT01899703 (ClinicalTrials.gov) | March 10, 2014 | 3/7/2013 | A 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 Pruritus | A 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 Pruritus | Cholestasis, Intrahepatic | Drug: GSK2330672;Drug: Placebo;Drug: Ursodeoxycholic acid | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 22 | Phase 2 | United Kingdom |