Actively Recruiting
Vonvendi Intravenous Specified Drug Use-results Survey Pediatric Administration
Led by Takeda · Updated on 2026-02-23
13
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating vonicog alfa (rVWF) for treating children with Von Willebrand Disease (vWD) in Japan. The study aims to assess both the safety, focusing on adverse drug reactions, and the effectiveness of rVWF in pediatric patients. This observational study records how the drug is used during routine care without altering standard treatment practices. Participants with vWD will receive vonicog alfa (rVWF) via intravenous injection as prescribed for managing bleeding episodes or during surgical procedures. The drug administration follows standard practice according to the approved package insert, and the study sponsor does not influence treatment decisions. The observation period for each participant lasts up to one year from the start of rVWF administration. During the study, researchers will monitor and document any adverse drug reactions and evaluate hemostatic effectiveness using a rating scale over one year. They will also track the number of infusions used per bleeding episode and during surgeries. Participants will be observed through their routine clinical visits, and the study will collect data on safety and treatment outcomes throughout this period.
CONDITIONS
Brief Title
An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 18 years old with Von Willebrand Disease (vWD).
- Receiving vonicog alfa (rVWF) for bleeding treatment or perioperative management.
- Prescription or administration of rVWF after its pediatric approval date in Japan.
You will not qualify if you...
- Currently participating in clinical trials of vonicog alfa (rVWF).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants who receive vonicog alfa (rVWF) for bleeding treatment or perioperative management are observed to assess safety and hemostatic efficacy.
Visits as needed based on bleeding episodes and perioperative periods
Trial Site Locations
Total: 1 location
1
Takeda selected site
Tokyo, Tokyo, Japan
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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