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 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| 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 | EUCTR2006-001383-23-DE (EUCTR) | 19/09/2013 | 21/05/2013 | Efficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedings | Efficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedings - PRO.WILL. | Patients with severe, inherited Von Willebrand’s disease and frequent bleedings MedDRA version: 16.0;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] | Trade Name: FANHDI*INF FL250UI+SIR SOLV+S Product Name: FANHDI 25 UI INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S Product Name: FANHDI 50 UI INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S Product Name: FANHDI 100 UI INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2006-001383-23-ES (EUCTR) | 24/05/2012 | 01/03/2012 | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings. | Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings. | Severe, inherited von Willebrand disease (VWD) and frequent bleedings 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] | Trade Name: Fanhdi 25 UI FVIII-30 UI FVW Product Name: Fanhdi 25 UI Other descriptive name: coagulación factor VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Fanhdi 50 UI FVIII-60 UI FVW Product Name: Fanhdi 50 UI Other descriptive name: coagulación factor VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Fanhdi 100 UI FVIII-120 UI FVW Product Name: Fanhdi 100 UI Other descriptive name: coagulación factor VIII Other descriptive name: HUMAN VON WILLEBRAND FACTOR | Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy |