An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)

Takeda

Status: Enrolling

Conditions: Von Willebrand Disease (vWD)

Treatments: Drug: vonicog alfa (rVWF)

Study type: Observational

Funder types: Industry

Identifiers

NCT07404644

jRCT2031250712 (Registry Identifier)

TAK-577-4010

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

13 participants in 1 patient group

vonicog alfa (rVWF) Group

Description:

Participants with Von Willebrand Disease (vWD) who received vonicog alfa (rVWF) in accordance with package insert.

Treatment:

Drug: vonicog alfa (rVWF)