An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)
Vonvendi Intravenous Specified Drug Use-results Survey "Pediatric Administration"
2 other identifiers
observational
13
1 country
1
Brief Summary
This study is conducted in Japan of vonicog alfa (rVWF) used to treat pediatric participants with Von Willebrand Disease (vWD). The main aim of the study is to evaluate adverse drug reaction and effectiveness of vonicog alfa (rVWF). During the study, pediatric participants with vWD will be administered with rVWF under routine normal practice. The investigators will evaluate adverse events due to rVWF for 1 year from the start of drug administration. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
February 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2031
February 23, 2026
February 1, 2026
5.3 years
February 5, 2026
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)
Adverse Event (AE) refers to any undesirable medical occurrence in a patient administered a drug, regardless of causal relationship. This includes any unfavorable or unintended sign (including abnormal laboratory findings), symptom, or disease occurring during administration, regardless of causal relationship. Adverse drug reaction (ADR) refers to AE related to administered drug.
Up to 1 year
Secondary Outcomes (4)
Hemostatic Efficacy Assessed by Hemostatic Efficacy Rating Scale
1 year
Hemostatic Efficacy during Perioperative Periods Assessed by Hemostatic Efficacy Rating Scale
1 year
Number of Infusions per Bleeding Episode
1 year
Number of Infusions during Perioperative Periods
1 year
Study Arms (1)
vonicog alfa (rVWF) Group
Participants with Von Willebrand Disease (vWD) who received vonicog alfa (rVWF) in accordance with package insert.
Interventions
rVWF administered by intravenous injection.
Eligibility Criteria
The population of this study are all participants who meet the inclusion/exclusion criteria.
You may qualify if:
- 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.
You may not qualify if:
- \- Patients who are participating in clinical trials of rVWF.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda selected site
Tokyo, Tokyo, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2026
First Posted
February 11, 2026
Study Start
February 19, 2026
Primary Completion (Estimated)
May 30, 2031
Study Completion (Estimated)
May 30, 2031
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).