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rVWF

Phase 3

Von Willebrand Disease (VWD) | Monoclonal antibody | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: Sep 3, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

rVWF · 1 trial · 1 indication

Phase 3 1
NCT03879135A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)Von Willebrand Disease (VWD)
COMPLETED38 Analytics
PHASE3COMPLETED
A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)
Von Willebrand Disease (VWD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Spontaneous Annualized Bleeding Rate (sABR)
Up to 12 months

sABR was derived as \[number of treated bleeds\] / \[duration in years\]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during the first 12 months of prophylactic treatment with rVWF (vonicog alfa) was reported.

Secondary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Up to 5.8 years
Number of Participants Based on Severity of TEAEs
Up to 5.8 years
Number of Participants Based on Causality of TEAEs
Up to 5.8 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
On-DemandEXPERIMENTALParticipants will receive recombinant von Willebrand factor (rVWF) (with or without ADVATE).
ProphylaxisEXPERIMENTALParticipants will receive recombinant von Willebrand factor (rVWF).

Interventions

NameTypeDescription
rVWFBIOLOGICALRecombinant von Willebrand factor
rFVIIIBIOLOGICALRecombinant Factor VIII
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Eligibility Criteria

Age Range0 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: The participant will not be considered eligible for the study without meeting all of the criteria below. Participants who have completed Study 071301 or Study 071102 (or participants who have completed the surgery arm treatment in Study 071102 and want to continue to receive on...

Countries:United StatesAustriaFranceGermanyItalyNetherlandsRussiaSpainTurkey (Türkiye)
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Competitive Landscape -Von Willebrand Disease 8 trials (matched to "Von Willebrand Disease (VWD)")

Frequently asked questions about rVWF

What is rVWF used for?

rVWF is a recombinant von Willebrand factor being studied for the treatment of Von Willebrand Disease (VWD), a bleeding disorder. It is intended for use in pediatric and adult patients with severe VWD. The drug is currently in Phase 3 clinical development and is not yet approved.

Who makes rVWF?

rVWF is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the safety and efficacy of rVWF in patients with severe Von Willebrand Disease.

What phase is rVWF in?

rVWF is in Phase 3 clinical development. A Phase 3 study has been completed, but the drug remains investigational and has not received regulatory approval. It is being studied for the treatment of severe Von Willebrand Disease in pediatric and adult patients.

What clinical trials is rVWF in?

rVWF has one completed Phase 3 clinical trial, identified as NCT03879135. This study evaluated rVWF in pediatric and adult participants with severe Von Willebrand Disease. The trial enrolled 38 participants and was conducted in multiple countries, including the United States, Austria, France, Germany, Italy, Netherlands, Russia, Spain, and Turkey.

Is rVWF the same as recombinant von Willebrand factor?

Yes, rVWF is the abbreviation for recombinant von Willebrand factor. It is a laboratory-made version of the von Willebrand factor protein, which is deficient or defective in people with Von Willebrand Disease. The drug is being developed to replace this missing protein and help control bleeding.