93. 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］
［臨床試験数：230，薬物数：215（DrugBank：51），標的遺伝子数：34，標的パスウェイ数：107］
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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-PL (EUCTR) | 22/06/2020 | 27/03/2020 | 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;United Kingdom;Japan | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Spain;Australia;Netherlands;Japan;United Kingdom | ||
| 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 |
| 6 | 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 |
| 7 | 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 |