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Marketed plasma-derived VWF/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

Marketed plasma-derived VWF/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

Frequently asked questions about Marketed plasma-derived VWF/FVIII

What is Marketered plasma-derived VWF/FVIII used for?

Marketed plasma-derived VWF/FVIII is used for the treatment of Von Willebrand Disease, a bleeding disorder. It is being developed by Takeda Pharmaceutical Company Limited and is currently in Phase 1 clinical development.

Who makes Marketered plasma-derived VWF/FVIII?

Marketed plasma-derived VWF/FVIII is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is being studied for the treatment of Von Willebrand Disease.

What phase is Marketered plasma-derived VWF/FVIII in?

Marketed plasma-derived VWF/FVIII is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Marketered plasma-derived VWF/FVIII in?

Marketed plasma-derived VWF/FVIII has one completed Phase 1 trial, NCT00816660, which studied the pharmacokinetics, safety, and tolerability of the drug in patients with Type 3 Von Willebrand Disease. The trial enrolled 32 participants across the United States, Austria, Canada, Germany, Italy, and the United Kingdom.

Is Marketered plasma-derived VWF/FVIII a monoclonal antibody?

Marketed plasma-derived VWF/FVIII is classified as a monoclonal antibody modality. It is being developed for the treatment of Von Willebrand Disease and is currently in Phase 1 clinical trials.