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 | NCT02472665 (ClinicalTrials.gov) | December 2013 | 10/6/2015 | Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease | Evaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand Disease | Von Willebrand Disease | Drug: plasma-derived FVIII/VWF concentrate | Grifols Therapeutics LLC | Instituto Grifols, S.A. | Recruiting | 2 Months | 6 Years | All | 8 | Phase 4 | Spain |
| 2 | EUCTR2012-003450-92-ES (EUCTR) | 23/11/2013 | 29/11/2012 | Evaluation of the dynamic behavior, efficacy and safety of Fanhdi®, a high-purity von Willebrand containing FVIII concentrate, in pediatric patients with von Willebrand disease. | EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WITH VON WILLEBRAND DISEASE - Study of Fanhdi® in pediatric patients with VWD | Severe von Willebrand disease including types I, II, and III with VWF:RCof <15-20% MedDRA version: 14.1;Level: PT;Classification code 10068986;Term: Von Willebrand's factor activity decreased;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Fanhdi | Instituto Grifols S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Spain | |||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | EUCTR2006-001383-23-IT (EUCTR) | 30/06/2006 | 28/11/2006 | 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 - PRO.WILL | 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 - PRO.WILL | patients with severe inherited VWD unresponsive to DDAVP and with frequent bleedings MedDRA version: 8.1;Level: PT;Classification code 10047715;Term: Von Willebrand's disease | Trade Name: ALPHANATE*INF 1F 1500UI+F 10ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI*INF FL 250UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 250UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 500UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 1000UI+F 10ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S INN or Proposed INN: Coagulation factor VIII Trade Name: ALPHANATE*INF 1F 250UI+F 5ML INN or Proposed INN: Coagulation factor VIII Trade Name: FANHDI 250UI*1F 250UI+F 10ML INN or Proposed INN: Coagulation factor VIII | FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Spain;Germany;United Kingdom;Italy |