Humate-P ( DrugBank: - )


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3

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_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2004-004868-69-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
2EUCTR2004-004868-69-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
3NCT00168090
(ClinicalTrials.gov)
October 200112/9/2005Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.Von Willebrand Disease;Blood Coagulation Disorders;Blood Platelet Disorders;Hematologic DiseaseDrug: Blood coagulation Factor VIII and vWF, humanCSL BehringNULLCompletedN/AN/ABoth30Phase 4United States