Von Willebrand Disease (vWD)NCT07404644
An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)
An observational study of Von Willebrand Disease (vWD), run by Takeda at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Von Willebrand Disease (vWD)
- What is being tested?
- vonicog alfa (rVWF)
- Type of treatment
- Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteJapan
- Study dates
- 19 Feb 2026to 30 May 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The population of this study are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Patients who are participating in clinical trials of rVWF.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vonvendi Intravenous Specified Drug Use-results Survey "Pediatric Administration"
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.
- Conditions
- Von Willebrand Disease (vWD)
- Being tested
- vonicog alfa (rVWF)
- Keywords
- Von Willebrand Disease (vWD)
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonicog alfa (rVWF)Drug
Also called Vonvendi Intravenous, Recombinant von Willebrand Factor (rVWF), TAK-577
rVWF administered by intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| vonicog alfa (rVWF) Group | Participants with Von Willebrand Disease (vWD) who received vonicog alfa (rVWF) in accordance with package insert. Receives: Drug: vonicog alfa (rVWF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (4)
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).
Measured: 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).
Measured: 1 year
Number of Infusions per Bleeding Episode
Measured: 1 year
Number of Infusions during Perioperative Periods
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start19 Feb 2026
- Primary completion30 May 2031 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand Disease (vWD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404644
- Sponsor's protocol ID
- TAK-577-4010
- Other IDs
- jRCT2031250712
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).