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COMPLETED Phase 3

A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)

NCT03879135 · View on ClinicalTrials.gov ↗

Study Summary

The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.

Interventions

  • BIOLOGICAL rVWF
  • BIOLOGICAL rFVIII

Study Locations (20)

Other

  • AKH - Medizinische Universität Wien — Vienna
  • Groupement Hospitalier Est- Hôpital Louis Pradel — Bron
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin — Gironde
  • Groupement Hospitalier Sud - Hôpital Bicêtre — Le Kremlin-Bicêtre
  • Klinikum der Johann Wolfgang Goethe-Universitaet — Frankfurt
  • Werlhof-Institut GmbH — Hanover
  • Azienda Ospedaliera Universitaria Careggi — Florence
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan
  • Azienda Ospedaliera Pediatrica Santobono Pausillipon — Naples
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Rainbow Babies and Children's Hospital — Cleveland
  • Nationwide Children's Hospital — Columbus

Arkansas

  • Arkansas Children's Hospital Research Institute — Little Rock

Colorado

  • University of Colorado Health — Aurora

Florida

  • University of Florida College of Medicine — Gainesville

Indiana

  • Indiana Hemophilia and Thrombosis Center — Indianapolis

South Carolina

  • Medical University of South Carolina (MUSC) — Charleston

Nord

  • Hopital Cardiologique - CHU Lille — Lille

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-04-01
Est. Completion 2025-01-30
Phase Phase 3

Sponsor

Baxalta now part of Shire

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03879135

The ClinicalTrials.gov registry entry for NCT03879135 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Von Willebrand Disease (VWD) appearing as the primary indexed condition, and to 2 interventions — of which rVWF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03879135 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Ohio, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03879135 about?

NCT03879135 is a clinical study titled "A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)". The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be tre...

What is the current status of trial NCT03879135?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2019-04-01. Estimated completion is 2025-01-30.

What conditions does trial NCT03879135 study?

This clinical trial studies the following conditions: Von Willebrand Disease (VWD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03879135?

The interventions under investigation include: rVWF (BIOLOGICAL), rFVIII (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03879135?

This trial is sponsored by Baxalta now part of Shire, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03879135 being conducted?

This trial has 20 study locations across Arkansas, Colorado, Florida, Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial