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NCT05582993 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Von Willebrand Disease (VWD), sponsored by Takeda.

Recruiting
Registry status
Phase 3
Development phase
24
Enrollment target
15
Study locations

NCT05582993: Recruiting Phase 3 study of Von Willebrand Disease (VWD), sponsored by Takeda.

NCT05582993 is a Phase 3 study of Von Willebrand Disease (VWD) that is actively recruiting participants, run by Takeda. The registered enrollment target is 24 participants, below the 103-participant average among 4 other Von Willebrand Disease (VWD) trials with a reported enrollment target (77% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05582993, a Phase 3 study of Von Willebrand Disease (VWD), is actively recruiting participants, sponsored by Takeda.

RECRUITING
Registry status
Phase 3
Development phase
24 participants
Enrollment target
15
Study locations

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.

Primary Outcome

ABR during the study compared to historical ABR for each participant for both spontaneous and traumatic bleeding episodes as classified by the investigator during prophylactic treatment with vonicog alfa (rVWF) will be reported.

Conditions Studied

Von Willebrand Disease (VWD)

Interventions

  • BIOLOGICAL Vonicog Alfa
  • BIOLOGICAL ADVATE

Study Locations (15)

Other

  • Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est) Bureau 419 - Lille
  • Hopital Edouard Herriot - CHU Lyon - Lyon
  • Children's Health Ireland - Dublin
  • Azienda Ospedaliera Pediatrica Santobono Pausillipon - Naples
  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino - Turin (Torino)
  • Nara Medical University Hospital - Kashihara

Alabama

  • University of Alabama at Birmingham - Birmingham

Illinois

  • Bleeding and Clotting Disorders Institute - Peoria

Indiana

  • Riley Hospital for Children Indiana University Health - Indianapolis

Iowa

  • University of Iowa Hospitals & Clinics PARENT - Iowa City

Michigan

  • Childrens Hospital of Michigan - Detroit

Minnesota

  • Children's Health Care d/b/a Children's Minnesota - Minneapolis

New Jersey

  • Rutgers - Robert Wood Johnson Medical School - New Brunswick

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2024-11-06
Est. Completion 2030-04-11
Phase Phase 3
Takeda

408 total trials

What NCT05582993 shows while recruiting

NCT05582993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 103-participant average among 4 other Von Willebrand Disease (VWD) trials with a reported enrollment target (77% lower).

The record links to 1 condition, with Von Willebrand Disease (VWD) appearing as the primary indexed condition, and to 2 interventions - of which Vonicog Alfa is the first listed.

NCT05582993 lists 15 locations in 10 states (Other, Alabama, Illinois).

Frequently Asked Questions

What is clinical trial NCT05582993 about?

NCT05582993 is a clinical study titled "A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)". 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 stud...

What is the current status of trial NCT05582993?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2024-11-06. Estimated completion is 2030-04-11.

What conditions does trial NCT05582993 study?

This clinical trial studies the following conditions: Von Willebrand Disease (VWD).

What interventions are being tested in trial NCT05582993?

The interventions under investigation include: Vonicog Alfa (BIOLOGICAL), ADVATE (BIOLOGICAL).

Who is sponsoring clinical trial NCT05582993?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05582993 being conducted?

This trial has 15 study locations across Alabama, Illinois, Indiana, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT05582993

Source: ClinicalTrials.gov NCT05582993, the US trial registry maintained by the National Library of Medicine. NCT05582993 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.