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Recombinant von Willebrand factor: recombinant FVIII

Phase 1

Von Willebrand Disease | Monoclonal antibody | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: May 3, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Recombinant von Willebrand factor: recombinant FVIII · 1 trial · 1 indication

Phase 1 1
NCT00816660Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand DiseaseVon Willebrand Disease
COMPLETED32 Analytics
PHASE1COMPLETED
Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease
Von Willebrand DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To demonstrate the immediate tolerability and safety after single-dose injections of rVWF:rFVIII at various doses
Up to 30 days after the last investigational product infusion
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII)BIOLOGICALSingle dose, dose escalation, various cohorts
Marketed plasma-derived VWF/FVIII concentrateBIOLOGICALCross-over: recombinant FVIII (rVWF:rFVIII) and marketed plasma-derived VWF/FVIII concentrate
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Subject has voluntarily given written informed consent (before conduct of any study-related procedures) * The subject has hereditary type 3 VWD (\<= 3 IU/dL VWF:Ag)or severe type 1 or type 2A VWD (VWF:RCo \<= 10% and FVIII:C \<20%) * The subject has a medical history of at lea...

Countries:United StatesAustriaCanadaGermanyItalyUnited Kingdom
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Competitive Landscape -Von Willebrand Disease 8 trials