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NCT Number: NCT07404644

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

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.

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Key information

Conditions

Von Willebrand Disease (VWD) Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vonicog alfa (rVWF)

Drug

rVWF administered by intravenous injection.

Other names: Vonvendi Intravenous, Recombinant von Willebrand Factor (rVWF), TAK-577

Primary outcomes

  1. Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)

    Time frame: 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 outcomes

  1. Hemostatic Efficacy Assessed by Hemostatic Efficacy Rating Scale

    Time frame: 1 year

    Hemostatic efficacy for bleeding episodes will be assessed by a predefined 4-point rating scale (Excellent, Good, Moderate, None).

  2. Hemostatic Efficacy during Perioperative Periods Assessed by Hemostatic Efficacy Rating Scale

    Time frame: 1 year

    Hemostatic efficacy during perioperative periods will be assessed by a predefined 4-point rating scale (Excellent, Good, Moderate, None).

  3. Number of Infusions per Bleeding Episode

    Time frame: 1 year

  4. Number of Infusions during Perioperative Periods

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Vonvendi Intravenous Specified Drug Use-results Survey "Pediatric Administration"

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Feb 11, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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