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

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ClinicalTrials.gov Identifier: NCT02466789
Recruitment Status : Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Blood Center of Wisconsin
Information provided by (Responsible Party):
Jonathan Roberts, Bleeding and Clotting Disorders Institute Peoria, Illinois

Tracking Information
First Submitted Date June 5, 2015
First Posted Date June 9, 2015
Last Update Posted Date August 6, 2019
Study Start Date July 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02466789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 8, 2015)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)
Official Title Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Sodium Citrated Plasma samples
Sampling Method Non-Probability Sample
Study Population New subjects undergoing evaluation for the diagnosis of VWD that are determined to have VWF:ag or VWF:RCo <50 IU/dl and or a VWF:RCo/VWF:ag ratio of <0.7. Also subjects will be included if Type 2N VWD is suspected
Condition Von Willebrands Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 8, 2015)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02466789
Other Study ID Numbers H14-25321
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jonathan Roberts, Bleeding and Clotting Disorders Institute Peoria, Illinois
Study Sponsor Jonathan Roberts
Collaborators Blood Center of Wisconsin
Investigators
Principal Investigator: Jonathan Roberts, MD Bleeding and Clotting Disorders Institute
PRS Account Bleeding and Clotting Disorders Institute Peoria, Illinois
Verification Date August 2019