Linerixibat (DrugBank: -)
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［原発性胆汁性肝硬変 (~2017.3)］ | 3 |
| 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 | NCT04167358 (ClinicalTrials.gov) | July 14, 2020 | 15/11/2019 | 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 | Cholestasis | Drug: Linerixibat | GlaxoSmithKline | NULL | Recruiting | 18 Years | 90 Years | All | 75 | Phase 3 | United States;Canada;Germany;Japan;Poland;Spain |
| 2 | 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 | ||
| 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 |