🏛️ Verified NIH Record • Updated 2026-05-22

A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) (NCT05582993)

A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis With Vonicog Alfa (rVWF) in Children Diagnosed With Severe Von Willebrand Disease

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Takeda

🩺 Plain-English Summary (8th-Grade Level)

The main aim of the study is to evaluate the effectiveness of prophylaxis with vonicog alfa (recombinant von Willebrand factor \[rVWF\]) in children. This study will enroll those participants who have been previously treated with VWF product or with a plasma-derived VWF (pdVWF) product. In this study, participants will be treated with vonicog alfa (rVWF) for 12 months. During the study, participants will visit the study clinic 5 times after treatment initiation.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham — Birmingham, Alabama

Age range: Not specified to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (21 Sites)

  • University of Alabama at Birmingham — Birmingham, Alabama
  • Bleeding and Clotting Disorders Institute — Peoria, Illinois
  • Riley Hospital for Children Indiana University Health — Indianapolis, Indiana
  • University of Iowa Hospitals & Clinics PARENT — Iowa City, Iowa
  • Childrens Hospital of Michigan — Detroit, Michigan
  • Michigan State University Center for Bleeding Disorders & Clotting Disorders — East Lansing, Michigan
  • Children's Health Care d/b/a Children's Minnesota — Minneapolis, Minnesota
  • Cure 4 the Kids — Las Vegas, Nevada
  • Rutgers - Robert Wood Johnson Medical School — New Brunswick, New Jersey
  • New York - Presbyterian/Weill Cornell Medical Center — New York, New York
  • Medical University of South Carolina (MUSC) — Charleston, South Carolina
  • Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est) Bureau 419 — Lille,
  • Hopital Edouard Herriot - CHU Lyon — Lyon,
  • Children's Health Ireland — Dublin,
  • Azienda Ospedaliera Pediatrica Santobono Pausillipon — Naples,
  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino — Turin (Torino),
  • Japanese Red Cross Narita Hospital — Narita, Chiba
  • Nara Medical University Hospital — Kashihara, Nara
  • NHO Beppu Medical Center — Beppu, Oita Prefecture
  • Nagasaki University Hospital — Nagasaki,
  • Haemophilia Comprehensive Care Centre, Great Ormond Street Hospital for Children NHS Foundation Trust — London,

📞 Contact the Study Coordinator

Phone: (877) 825-3327

Email: medinfoUS@takeda.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗