Vonicog alfa (rVWF) use in children with von Willebrand disease
Vonvendi Intravenous Specified Drug Use-results Survey "Pediatric Administration"
This observational program will see how vonicog alfa (rVWF) works and whether it causes side effects in children with von Willebrand disease in Japan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 13 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo, Tokyo) |
| Trial ID | NCT07404644 on ClinicalTrials.gov |
What this trial studies
This is an observational follow-up of pediatric patients in Japan who are given vonicog alfa (rVWF) as part of routine care for bleeding episodes or around surgery. Investigators will record adverse drug reactions and clinical effectiveness for one year after the start of rVWF administration. Treatment decisions are made by the patients' physicians under normal practice and the sponsor will only collect data on what happens. Patients already enrolled in other rVWF clinical trials are excluded.
Who should consider this trial
Good fit: Children under 18 with von Willebrand disease who receive vonicog alfa for hemostatic treatment during bleeding episodes or perioperative periods in Japan, with administration after pediatric approval, are ideal candidates.
Not a fit: Adults, children not treated with rVWF, or patients enrolled in other rVWF clinical trials are not expected to benefit from participation in this observational program.
Why it matters
Potential benefit: If successful, the study could provide real-world pediatric safety and effectiveness data to help clinicians and families make more informed treatment decisions.
How similar studies have performed: Recombinant VWF products have shown efficacy and acceptable safety in adults and some pediatric reports, but comprehensive real-world pediatric data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * Under 18 years old with vWD. * Participants who are treated with rVWF for the purpose of hemostatic treatment and management during bleeding episodes or perioperative periods. * Participants who have prescription or administration after the approval date of rVWF for pediatric use in Japan. Exclusion Criteria : \- Patients who are participating in clinical trials of rVWF.
Where this trial is running
Tokyo, Tokyo
- Takeda selected site — Tokyo, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.