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Evaluation of a Simple Pharmacokinetic Tool (myPKFiT™) to Guide Personalized Factor VIII Dosing in Patients With Hemophilia

NCT02750085 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2020-05-15

No results posted yet for this study

Summary

This is an investigator-initiated, industry-funded, multi-centre, international study that will be carried out prospectively at hemophilia treatment centres across Canada, the Czech Republic and Australia with SickKids as the coordinating site. The study will use a central laboratory not directly affiliated with any of the participating sites. Enrollment target is 50 participants, both adult and pediatric with severe hemophilia A receiving Advate, who will each complete a 2-point and 6-point pharmacokinetic (PK) sampling. The main aim is to compare the results of a 2 sample PK using clinically practical time points and myPKFiT™ (a web-based, population PK Bayesian tool) to a 6 sample population PK to determine whether the results obtained are in good agreement.

Conditions

Sponsors & Collaborators

  • St. Paul's Hospital

    collaborator UNKNOWN

  • Montreal Children's Hospital of the MUHC

    collaborator OTHER

  • Queen's University

    collaborator OTHER

  • University Hospital, Motol

    collaborator OTHER

  • The University Hospital Brno

    collaborator UNKNOWN

  • Royal Children's Hospital

    collaborator OTHER

  • Sydney Children's Hospitals Network

    collaborator OTHER

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • Victor Blanchette

    lead OTHER

Principal Investigators

  • Victor S Blanchette, MD · The Hospital for Sick Children

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-01-31
Completion
2020-12-31

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Entities

Diseases

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 NCT02750085 on ClinicalTrials.gov