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A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)

NCT05582993 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-15

No results posted yet for this study

Summary

The main aim of the study is to evaluate the effectiveness of prophylaxis with vonicog alfa (recombinant von Willebrand factor \[rVWF\]) in children. This study will enroll those participants who have been previously treated with VWF product or with a plasma-derived VWF (pdVWF) product. In this study, participants will be treated with vonicog alfa (rVWF) for 12 months.

During the study, participants will visit the study clinic 5 times after treatment initiation.

Conditions

  • Von Willebrand Disease (VWD)

Interventions

BIOLOGICAL

Vonicog Alfa

Vonicog Alfa administered by intravenous injection.

BIOLOGICAL

ADVATE

ADVATE administered by intravenous injection.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2030-04-11
Completion
2030-04-11
FDA Drug
Yes

Countries

  • United States
  • France
  • Ireland
  • Italy
  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582993 on ClinicalTrials.gov