93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
| 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-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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |