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NCT03879135 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Von Willebrand Disease (VWD), sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 3
Development phase
38
Enrollment target
20
Study locations

NCT03879135: Completed Phase 3 study of Von Willebrand Disease (VWD), sponsored by Baxalta now part of Shire.

NCT03879135 is a Phase 3 study of Von Willebrand Disease (VWD) that has completed, run by Baxalta now part of Shire. The registered enrollment target is 38 participants, below the 100-participant average among 4 other Von Willebrand Disease (VWD) trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03879135, a Phase 3 study of Von Willebrand Disease (VWD), has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 3
Development phase
38 participants
Enrollment target
20
Study locations

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.

Primary Outcome

sABR was derived as \[number of treated bleeds\] / \[duration in years\]. Bleeds with unknown causality were considered as spontaneous. Bleeds were categorized based on the investigator assessment of cause. sABR during the first 12 months of prophylactic treatment with rVWF (vonicog alfa) was reported.

Conditions Studied

Von Willebrand Disease (VWD)

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
Baxalta now part of Shire

74 total trials

What the finished NCT03879135 record still lists

NCT03879135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 100-participant average among 4 other Von Willebrand Disease (VWD) trials with a reported enrollment target (62% lower).

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.

NCT03879135 names 20 study sites across 9 states, led by Other, Ohio, Arkansas.

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).

What interventions are being tested in trial NCT03879135?

The interventions under investigation include: rVWF (BIOLOGICAL), rFVIII (BIOLOGICAL).

Who is sponsoring clinical trial NCT03879135?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

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.

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Related registry views

Source: ClinicalTrials.gov NCT03879135, the US trial registry maintained by the National Library of Medicine. NCT03879135 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.