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 : 206 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21

  
2 trials found
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-ES
(EUCTR)
24/05/201201/03/2012Efficacy, 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.Efficacy, 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. Severe, inherited von Willebrand disease (VWD) and frequent bleedings
MedDRA version: 14.1;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 25 UI FVIII-30 UI FVW
Product Name: Fanhdi 25 UI
Other descriptive name: coagulación factor VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: Fanhdi 50 UI FVIII-60 UI FVW
Product Name: Fanhdi 50 UI
Other descriptive name: coagulación factor VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: Fanhdi 100 UI FVIII-120 UI FVW
Product Name: Fanhdi 100 UI
Other descriptive name: coagulación factor VIII
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Fondazione IRCCS Cà Granda-Ospedale Maggiore PoliclinicoNULLNot RecruitingFemale: yes
Male: yes
24Phase 3Spain;Germany;United Kingdom;Italy