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 | EUCTR2018-001631-46-NL (EUCTR) | 14/02/2019 | 13/02/2019 | Effects of pharmacokinetic models in dosing of DDAVP and/or von Willebrand factor-containing concentrates in patients with von Willebrand disease | Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease - OPTI-CLOT: To WiN | Von Willebrand disease MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Minrin INN or Proposed INN: DESMOPRESSIN Trade Name: Octostim INN or Proposed INN: DESMOPRESSIN Trade Name: Octostim INN or Proposed INN: DESMOPRESSIN Trade Name: Haemate P INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR INN or Proposed INN: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII Trade Name: Wilate INN or Proposed INN: HUMAN COAGULATION FACTOR VIII Other descriptive name: HUMAN COAGULATION FACTOR VIII INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Wilfactin INN or Proposed INN: HUMAN VON WILLEBRAND FACTOR Other descriptive name: HUMAN VON WILLEBRAND FACTOR Trade Name: Veyvondi INN or Proposed INN: VON WILLEBRAND FACTOR Other descriptive name: VON WILLEBRAND FACTOR | Erasmus University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 2 | NCT00994929 (ClinicalTrials.gov) | January 2010 | 12/10/2009 | Efficacy and Safety of IL-11 in DDAVP Unresponsive | Phase II Biologic Effects Study of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Moderate or Mild Hemophilia A, or Von Willebrand Disease Unable to Use DDAVP | Hemophilia A;Von Willebrand Disease | Biological: Neumega (Oprelvekin, Interleukin 11, IL-11) | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 9 | Phase 2 | United States |
| 3 | 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 | ||
| 4 | EUCTR2005-004496-38-DK (EUCTR) | 22/06/2006 | 09/05/2006 | Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy. | Desmopressin in the management of von Willebrand disease; Biological versus clinical efficacy. | von Willebrand disease (VWD) is an inherited bleeding disorder, characterised mainly by mucosal bleedings, which may be life-threatening, and joint bleeds in severe VWD cases. VWD is caused by a lack of von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Treatment of VWD aims at normalizing the VWF activity in plasma, which can be achieved by stimulating the endogenous release of VWF with desmopressin (DDAVP, 1-desamino-8-D arginine vasopressin) or by infusion of a VWF concentrate. | Trade Name: Octostim Product Name: Octostim Product Code: DDAVP (Desmopressin) Trade Name: Octostim Product Name: Octostim Product Code: DDAVP (Desmopressin) | Rigshospitalet, Copenhagen | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Denmark |