Trials / Unknown
UnknownNCT02750085
Evaluation of a Simple Pharmacokinetic Tool (myPKFiT™) to Guide Personalized Factor VIII Dosing in Patients With Hemophilia
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 39 (actual)
- Sponsor
- Victor Blanchette · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2019-01-01
- Completion
- 2020-12-01
- First posted
- 2016-04-25
- Last updated
- 2020-05-15
Source: ClinicalTrials.gov record NCT02750085. Inclusion in this directory is not an endorsement.