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.
Study Type
OBSERVATIONAL
Enrollment
13
rVWF administered by intravenous injection.
Takeda selected site
Tokyo, Tokyo, Japan
RECRUITINGNumber 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.