About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
The population of this study are all participants who meet the inclusion/exclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
vonicog alfa (rVWF)
DrugrVWF administered by intravenous injection.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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).
Number of Infusions per Bleeding Episode
Number of Infusions during Perioperative Periods