VOLIXIBAT ( DrugBank: Volixibat )
2 diseases
| 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 | 2 |
| 94 | 原発性硬化性胆管炎 | 2 |
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. | 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 | EUCTR2021-001389-39-DE (EUCTR) | 19/04/2022 | 01/10/2021 | A study to evaluate efficacy and safety of an investigational drug namedvolixibat in patients with itching caused by primary biliary cholangitis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluatethe Efficacy and Safety of Volixibat in the Treatment of CholestaticPruritus in Patients with Primary Biliary Cholangitis (VANTAGE) - VANTAGE | Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: volixibat INN or Proposed INN: volixibat potassium Other descriptive name: volixibat Product Name: volixibat INN or Proposed INN: volixibat potassium Other descriptive name: volixibat | Mirum Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | France;United States;Canada;Israel;Germany;United Kingdom;Italy | ||
| 2 | NCT05050136 (ClinicalTrials.gov) | September 22, 2021 | 9/9/2021 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis;PBC | Drug: Volixibat;Drug: Placebo | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 260 | Phase 2 | United States;France;Germany;Israel;United Kingdom |
94. 原発性硬化性胆管炎
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| 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 | EUCTR2020-003027-41-DE (EUCTR) | 17/11/2021 | 17/06/2021 | A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitis | A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS) - VISTAS | Pruritus associated with Primary Sclerosing Cholangitis (PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Volixibat (formely SHP626, LUM002 or SAR548304B) INN or Proposed INN: Volixibat potassium Other descriptive name: VOLIXIBAT Product Name: Volixibat (formely SHP626, LUM002 or SAR548304B) INN or Proposed INN: Volixibat potassium Other descriptive name: VOLIXIBAT | Mirum Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Canada;Israel;Germany;United Kingdom | ||
| 2 | NCT04663308 (ClinicalTrials.gov) | December 18, 2020 | 17/11/2020 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) | A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Volixibat;Drug: Placebo | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | 16 Years | N/A | All | 200 | Phase 2 | United States;Canada;Germany;Israel;United Kingdom |