FANHDI*INF FL 500UI+SIR SOLV+S ( 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2

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
1EUCTR2006-001383-23-DE
(EUCTR)
19/09/201321/05/2013Efficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedingsEfficacy, safety and pharmaco-economic assessment ofsecondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWDand frequent bleedings - PRO.WILL. Patients with severe, inherited Von Willebrand’s disease and frequent bleedings
MedDRA version: 16.0;Level: PT;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: FANHDI*INF FL250UI+SIR SOLV+S
Product Name: FANHDI 25 UI
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: FANHDI*INF FL 500UI+SIR SOLV+S
Product Name: FANHDI 50 UI
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Trade Name: FANHDI*INF FL1000UI+SIR SOLV+S
Product Name: FANHDI 100 UI
INN or Proposed INN: HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoNULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy
2EUCTR2006-001383-23-IT
(EUCTR)
30/06/200628/11/2006Efficacy, 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.WILLEfficacy, 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 BONOMINULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy