Fanhdi ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
288Autoimmune acquired coagulation factor deficiency5

288. Autoimmune acquired coagulation factor deficiency


Clinical trials : 205 Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26
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PhaseCountries
1NCT02472665
(ClinicalTrials.gov)
December 201310/6/2015Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand DiseaseEvaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand DiseaseVon Willebrand DiseaseDrug: plasma-derived FVIII/VWF concentrateGrifols Therapeutics LLCInstituto Grifols, S.A.Recruiting2 Months6 YearsAll8Phase 4Spain
2EUCTR2012-003450-92-ES
(EUCTR)
23/11/201329/11/2012Evaluation of the dynamic behavior, efficacy and safety of Fanhdi®, a high-purity von Willebrand containing FVIII concentrate, in pediatric patients with von Willebrand disease.EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WITH VON WILLEBRAND DISEASE - Study of Fanhdi® in pediatric patients with VWD Severe von Willebrand disease including types I, II, and III with VWF:RCof <15-20%
MedDRA version: 14.1;Level: PT;Classification code 10068986;Term: Von Willebrand's factor activity decreased;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Classification code 10047715;Term: Von Willebrand's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: FanhdiInstituto Grifols S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8Spain
3EUCTR2006-001383-23-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
4EUCTR2006-001383-23-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
5EUCTR2006-001383-23-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