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 | EUCTR2010-023666-46-PL (EUCTR) | 13/12/2011 | 20/12/2011 | A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERY | EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES | HAEMOPHILIA A MedDRA version: 14.1;Level: LLT;Classification code 10018938;Term: Haemophilia A (Factor VIII);System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: FACTANE 200 IU/ml Product Code: F8VR Other descriptive name: HUMAN COAGULATION FACTOR VIII | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: no Male: yes | Poland | ||||
| 2 | EUCTR2007-004943-31-SE (EUCTR) | 03/10/2007 | 12/09/2007 | The VWD International Prophylaxis (VIP) Study - VIP study | The VWD International Prophylaxis (VIP) Study - VIP study | Severe form of von Willebrand disease | Trade Name: Haemate-P, Wilate Product Name: VWD factor VIII concentrate Product Code: Factor VIII | Centre of Thrombosis and Haemostasis | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Sweden | |||
| 3 | EUCTR2004-004868-69-SE (EUCTR) | 25/04/2005 | 09/03/2005 | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD. MedDRA version: 7.1;Level: LLT;Classification code 10047715 | Trade Name: Humate-P Product Name: Humate-P Other descriptive name: Von Willebrand Factor Ristocetin Cofactor INN or Proposed INN: Factor VIII concentrate Other descriptive name: Factor VIII concentrate Other descriptive name: Von Willebrand Factor Antigen | ZLB Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 30 | Sweden | |||
| 4 | EUCTR2004-004868-69-AT (EUCTR) | 07/03/2005 | 31/01/2005 | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD. MedDRA version: 7.1;Level: LLT;Classification code 10047715 | Trade Name: Humate-P Product Name: Humate-P Other descriptive name: Von Willebrand Factor Ristocetin Cofactor INN or Proposed INN: Factor VIII concentrate Other descriptive name: Factor VIII concentrate Other descriptive name: Von Willebrand Factor Antigen | ZLB Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria;Sweden | |||
| 5 | NCT02246881 (ClinicalTrials.gov) | October 2001 | 2/9/2014 | A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A. | An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients. | Von Willebrand Disease | Biological: Optivate® (Human Coagulation Factor VIII) | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | Phase 3 | Poland;United Kingdom |