288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 206 / 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
| 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 | EUCTR2010-021162-30-BG (EUCTR) | 20/12/2011 | 07/12/2011 | This study in an open label study that is conducted in many centers around the world to investigate whether Wilate is safe and works in patients that need surgery and have von Willebrand disease. | Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate®) In Subjects With Inherited Von Willebrand Disease (VWD) Who Undergo Surgical Procedures. | Surgery in Inherited Von Willebrand Disease (VWD) MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: WILATE 500 I.U. Product Code: WILATE 500 I.U. Other descriptive name: Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) Product Name: WILATE 1000 I.U. Product Code: WILATE 1000 I.U. Other descriptive name: Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII) | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Russian Federation;Bulgaria;Italy;India | ||
| 2 | EUCTR2010-021162-30-IT (EUCTR) | 20/09/2011 | 07/03/2012 | Clinical trial to test if the study drug is safe and if it works well in severe Type 3 von Willebrand patients that need to have a major surgery. | Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate) In Subjects With Inherited Type 3 Von Willebrand Disease (VWD) Who Undergo Major Surgical Procedures. - WIL-24 | Surgery in Inherited Von Willebrand Disease (VWD) MedDRA version: 14.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Wilate 500 I.U. Product Code: Wilate 500 I.U. INN or Proposed INN: NA Other descriptive name: Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII) Product Name: Wilate 1000 I.U. Product Code: Wilate 1000 I.U. INN or Proposed INN: NA Other descriptive name: Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII) | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 41 | Phase 3 | United States;Turkey;Bulgaria;Russian Federation;Italy;India |