Recruiting

Observational Study

Sponsor:

VWD Connect Foundation

Code:

NCT05437536

Conditions

VWD - Von Willebrand's Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

A web-based registry will be created by the sponsor, VWD Connect Foundation (VCF), to collect data on patients with severe Von Willebrand Disease (sVWD). Data will be self-reported by patients and/or collected by registry personnel, as appropriate. The purpose of the sVWD Patient Registry is to create a database of well-characterized (with respect to demographics, medical history, symptoms, laboratory and genetic data, etc.) patients with sVWD for participation in retrospective and prospective research.

Conditions

VWD - Von Willebrand's Disease

Study ID

NCT05437536

Start date

Dec 10, 2021

Status verified date

Apr, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Anyone meeting the diagnostic classification for von Willebrand disease
2. Any VWF antigen or activity:

a. Result <20% regardless of bleeding phenotype, or b. Result <30% with excessive bleeding symptoms including: i. Bleeding that resulted in hospitalization, required surgical procedure, red blood cell transfusion, Hemoglobin decrease >2g/dL, or ii. Intracranial, intraspinal, pericardial, retroperitoneal, intramuscular bleeding with compartment syndrome, or iii. Persistent or recurrent bleeding that is disruptive of work or school.
3. Provide informed consent by participant or legally authorized representative
4. Be willing and able to comply with study procedures and data collection
5. Reside in the United States

NOTE: For inclusion criteria 1 and 2, it is not expected that participants will submit evidence of clinical diagnosis at screening; a participant's own confirmation that they have severe VWD will be sufficient for meeting the enrollment requirement and obtaining access to the registry. Laboratory values will be provided during the conduct of the study, and participants with VWF antigen or activity not meeting inclusion criterion 2 may be excluded from data analysis on a case-by-case basis in consultation with a subcommittee of the VWD Connect Foundation Medical and Scientific Advisory Board.

Exclusion Criteria:

1\. Have a clinical diagnosis of acquired VWD

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Outcomes are not applicable; this study is a patient registry. [ Time Frame: At least 5 years ]

Central Contacts and Locations

Central contacts

Christina Morgenthaler, MS, MBA

(279) 346-6202morgenthaler@vwdregistry.org

Locations

VWD Connect Foundation

Recruiting

Wellington, Florida, United States, 33414

Contacts

Christina Morgenthaler, MS, MBA

(279) 346-6202morgenthaler@vwdregistry.org

More Information

Sponsor

VWD Connect Foundation

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • VWD
  • Severe VWD
  • VWD Type 1 Severe
  • VWD Type 1C
  • VWD Type 2A
  • VWD Type 2B Severe
  • VWD Type 2M Severe
  • VWD Type 2N Severe
  • VWD Type 3
  • Von Willebrand Disease
  • VWB
  • Von Willebrands Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VWD Connect Foundation on 2026-04-22.