Von Willebrand Disease (vWD)
Conditions
Keywords
Von Willebrand Disease (vWD)
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.
Interventions
DRUGvonicog alfa (rVWF)
rVWF administered by intravenous injection.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
: * 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.
Exclusion criteria
: \- Patients who are participating in clinical trials of rVWF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic Efficacy Assessed by Hemostatic Efficacy Rating Scale | 1 year | 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 | 1 year | 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 | 1 year | — |
| Number of Infusions during Perioperative Periods | 1 year | — |
Countries
Japan
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed