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NCT Number: NCT02466789

Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)

The purpose of this study is to improve the investigators ability to diagnose von Willebrand Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening blood test used to determine if a person has VWD. This new screening blood test can determine a diagnosis more rapidly than current blood tests. Also this test could be available at local hospital labs rather than require samples to be sent to bigger more specialized labs.

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Key information

Conditions

Von Willebrands Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases von Willebrand Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bleeding and Clotting Disorders Institute

Peoria, Illinois, 61615, United States

About this study

This investigation will be a prospective, multicenter trial to validate the clinical utility of a novel screening assay as a diagnostic screening assay for VWD variants: Type 1C, 2A, 2B, 2M and 2N. Once the subject is enrolled into the study, a minimum of 0.5ml of citrated plasma will be collected and analyzed at the Bleeding and Clotting Disorders Institute Laboratory in Peoria Illinois. Results will be collected: phenotype function profiles will be determined, statistically analyzed and compared to the qualitative data from Blood Center of Wisconsin. Data is expected to correlate as previously shown in prior studies and will confirm the utility of this assay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New subjects undergoing evaluation for the diagnosis of VWD determined to have a VWF:Ag or VWF: RCo < 50 IU/dl and or a VWF:RCo/VWF:Ag of <0.7. Also subjects will be included if Type 2 N VWD is clinically suspected

Exclusion criteria

  • Those subjects whose lab results do not meet the inclusion criteria

Treatment and study plan

Primary outcomes

  1. Validate the novel ELISA-based VWF functional screening assay as a diagnostic screening assay to assign VWD phenotypes 1C, 2A, 2B, 2M and 2N.

    Time frame: planned analysis at 2 years and 4 years with study duration estimated at 4 years

Secondary outcomes

  1. Further development of the VWF functional screening assay through investigating the incorporation of VWF:CB6 (binding to collagen VI)

    Time frame: study duration 4 years

Sponsors and collaborators

Lead sponsor

Jonathan Roberts

Other

Collaborators

  • Versiti Blood Health

Registry information

Acronym: VWF-phV

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jun 9, 2015
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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