An observational study in Von Willebrand Disease (vWD), sponsored by Takeda. Recruiting at 1 site in Japan. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Takeda · Observational
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.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population of this study are all participants who meet the inclusion/exclusion criteria.
Exclusion Criteria :
- Patients who are participating in clinical trials of rVWF.
Participants with Von Willebrand Disease (vWD) who received vonicog alfa (rVWF) in accordance with package insert.
Drug: vonicog alfa (rVWF)
rVWF administered by intravenous injection.
Also known as: Vonvendi Intravenous, Recombinant von Willebrand Factor (rVWF), TAK-577
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.
Time frame: Up to 1 year
Hemostatic Efficacy Assessed by Hemostatic Efficacy Rating Scale
Hemostatic efficacy for bleeding episodes will be assessed by a predefined 4-point rating scale (Excellent, Good, Moderate, None).
Time frame: 1 year
Hemostatic Efficacy during Perioperative Periods Assessed by Hemostatic Efficacy Rating Scale
Hemostatic efficacy during perioperative periods will be assessed by a predefined 4-point rating scale (Excellent, Good, Moderate, None).
Time frame: 1 year
Number of Infusions per Bleeding Episode
Time frame: 1 year
Number of Infusions during Perioperative Periods
Time frame: 1 year
Plan to share: No — 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).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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von Willebrand Diseases
Takeda