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Study of Biostate® in Children With Von Willebrand Disease

NCT01213446 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-10-03

No results posted yet for this study

Summary

This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand disease (VWD) in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.

Conditions

  • Von Willebrand Disease

Interventions

BIOLOGICAL

Biostate

PK component: Single bolus infusion of 80 IU VWF:RCo/kg administered intravenously on Day 1, and approximately Day 180 in Type 3 VWD subjects only. Efficacy component: Repeated bolus doses over 12 months as required to manage VWD condition.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Director, Clinical R&D · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belarus
  • Georgia
  • Germany
  • Guatemala
  • Lebanon
  • Ukraine

Study Locations

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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 NCT01213446 on ClinicalTrials.gov