Factor XIII Concentrate (Human) ( DrugBank: Factor XIII )


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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-010722-19-ES
(EUCTR)
04/11/200911/08/2009A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIIIA Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII
MedDRA version: 9.1;Level: LLT;Classification code 10016083;Term: Factor XIII deficiency
Trade Name: Fibrogammin® P
Product Name: Factor XIII Concentrate (Human), Pasteurized
INN or Proposed INN: Factor XIII Concentrate (Human), Pasteurized
CSL Behring LLCNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Spain
2EUCTR2009-010387-41-ES
(EUCTR)
25/06/200916/04/2009A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII DeficiencyEstudio de 12 semanas, multicéntrico, de farmacocinética y seguridad del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIIIA 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII DeficiencyEstudio de 12 semanas, multicéntrico, de farmacocinética y seguridad del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII
MedDRA version: 9.1;Level: LLT;Classification code 10016083;Term: Factor XIII deficiency
Trade Name: Fibrogammin®P
Product Name: Factor XIII Concentrate (Human), Pasteurized
INN or Proposed INN: Factor XIII Concentrate (Human), Pasteurized
CSL Behring LLCNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Spain
3EUCTR2014-003764-20-Outside-EU/EEA
(EUCTR)
11/03/2015An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency Congenital Factor XIII deficiency
MedDRA version: 17.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Cluvot
INN or Proposed INN: Factor XIII Concentrate (Human)
CSL Behring LLCNULLNAFemale: yes
Male: yes
61United States