An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment

Part of paid clinical trials in Sacramento, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT06883240
Status
Recruiting
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Conditions

  • Von Willebrand Disease, Type 3

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Von Willebrand Factor Concentrates — DRUG
    Used according to local labeling or local treatment guidelines.
  • Von Willebrand Factor Concentrates and Factor VIII Concentrates — DRUG
    Used according to local labeling or local treatment guidelines.
  • Factor VIII Concentrates — DRUG
    Used according to local labeling or local treatment guidelines.
  • Recombinant Activated Factor VII — DRUG
    Used according to local labeling or local treatment guidelines.
  • Activated Prothrombin Complex Concentrate — DRUG
    Used according to local labeling or local treatment guidelines.

Study Details

This non-interventional study (NIS) is designed to collect information on the effectiveness and safety of treatment received in routine clinical care, as well as measure the health-related quality of life (HRQoL) of participants with Type 3 von Willebrand disease (VWD) receiving prophylactic therapy per local standard of care (SOC) over an observation period of at least 24 weeks.

Key Dates

Start date
Apr 29, 2025
Status verified
Jun 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Participants with Type 3 VWD Treated with Prophylactic SOC
    Participants with Type 3 VWD, aged 2 years and above, who are currently on standard of care (SOC) prophylactic therapy are anticipated to remain on the chosen SOC regimen during the study. Dosing and treatment duration of any studied medicinal products collected as part of this study are at the discretion of the treating physician in accordance with local labeling or local treatment guidelines.

Primary Outcome Measure

Annualized Bleed Rate (ABR) for Treated Bleeds [ Time Frame: From Baseline to at least 24 weeks ]

Central Contacts

  • Reference Study ID Number: WP45335 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (4)

FacilityCityStateZIPSite coordinators
UC DavisSacramentoCalifornia95817-
University of FloridaGainesvilleFlorida32610-
University of Minnesota Medical CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in Sacramento, CA

By research site
UC Davis· Sacramento, CAUniversity of Florida· Gainesville, FLUniversity of Minnesota Medical Center· Minneapolis, MNWashington University School of Medicine· St Louis, MO

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