Factor VIII concentrate ( DrugBank: Factor VIII )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
288自己免疫性後天性凝固因子欠乏症5

288. 自己免疫性後天性凝固因子欠乏症


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.TrialIDDate_
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PhaseCountries
1EUCTR2010-023666-46-PL
(EUCTR)
13/12/201120/12/2011A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERYEFFICACY 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 BIOTECHNOLOGIESNULLNot RecruitingFemale: no
Male: yes
Poland
2EUCTR2007-004943-31-SE
(EUCTR)
03/10/200712/09/2007The VWD International Prophylaxis (VIP) Study - VIP studyThe VWD International Prophylaxis (VIP) Study - VIP study Severe form of von Willebrand diseaseTrade Name: Haemate-P, Wilate
Product Name: VWD factor VIII concentrate
Product Code: Factor VIII
Centre of Thrombosis and HaemostasisNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Sweden
3EUCTR2004-004868-69-SE
(EUCTR)
25/04/200509/03/2005Study 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 DiseaseStudy 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 LLCNULLNot RecruitingFemale: yes
Male: yes
30Sweden
4EUCTR2004-004868-69-AT
(EUCTR)
07/03/200531/01/2005Study 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 DiseaseStudy 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 LLCNULLNot RecruitingFemale: yes
Male: yes
30Austria;Sweden
5NCT02246881
(ClinicalTrials.gov)
October 20012/9/2014A 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 DiseaseBiological: Optivate® (Human Coagulation Factor VIII)Bio Products LaboratoryNULLCompleted12 YearsN/AAllPhase 3Poland;United Kingdom