RecruitingPhase 3NCT05582993

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

A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis With Vonicog Alfa (rVWF) in Children Diagnosed With Severe Von Willebrand Disease

Sponsor

Takeda

Enrollment

24 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Von Willebrand Disease (vWD)

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.

Eligibility

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ADVATE and a biological treatment called Vonicog Alfa for people with von willebrand disease (vwd). The study is currently recruiting participants at 21 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVonicog Alfa

Vonicog Alfa administered by intravenous injection.

BIOLOGICALADVATE

ADVATE administered by intravenous injection.

Locations(21)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Bleeding and Clotting Disorders Institute

Peoria, Illinois, United States

Riley Hospital for Children Indiana University Health

Indianapolis, Indiana, United States

University of Iowa Hospitals & Clinics PARENT

Iowa City, Iowa, United States

Childrens Hospital of Michigan

Detroit, Michigan, United States

Michigan State University Center for Bleeding Disorders & Clotting Disorders

East Lansing, Michigan, United States

Children's Health Care d/b/a Children's Minnesota

Minneapolis, Minnesota, United States

Cure 4 the Kids

Las Vegas, Nevada, United States

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

New York - Presbyterian/Weill Cornell Medical Center

New York, New York, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est) Bureau 419

Lille, France

Hopital Edouard Herriot - CHU Lyon

Lyon, France

Children's Health Ireland

Dublin, Ireland

Azienda Ospedaliera Pediatrica Santobono Pausillipon

Naples, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Turin (Torino), Italy

Japanese Red Cross Narita Hospital

Narita, Chiba, Japan

Nara Medical University Hospital

Kashihara, Nara, Japan

NHO Beppu Medical Center

Beppu, Oita Prefecture, Japan

Nagasaki University Hospital

Nagasaki, Japan

Haemophilia Comprehensive Care Centre, Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05582993

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