UK-PK study
Research type
Research Study
Full title
National Study of the Implementation of a Pharmacokinetic Focused Educational Package for patients living with Severe Haemophilia A.
IRAS ID
177141
Contact name
Dan Hart
Contact email
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
A new dosing tool called myPKFiT® has been developed for people with haemophilia who follow a prophylactic treatment regimen. This is being introduced as part of day-to-day care in haemophilia centres across the UK to help tailor prophylactic treatment. This tool works by calculating what happens to factor VIII treatment once a patient has injected it, this is a process called pharmacokinetics or PK. PK tracks what happens with the factor VIII from the second it enters the body from the syringe to the moment it leaves the body. It lets us know how high factor levels peak and how long it takes until there is no factor VIII left in the blood. PK can be very different between different people. This means that individuals may need very different ways of managing their prophylaxis. myPKFiT® helps individual patients and their haemophilia team to look at the different treatment options available to them.
In this study we want to observe what happens when myPKFiT® is used in day-to-day practice. We will capture patient reported outcome measures before and after pharmacokinetic (PK) focused dosing discussions, and examine if and how individual treatment regimens may change.
The pragmatic study design recognises the CE marked myPKFiT® device is being implemented into routine care nationally and consequently only requires a single additional clinic visit for the purpose of consenting. Minimal additional blood sampling will be performed as part of the study protocol.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
15/WM/0218
Date of REC Opinion
15 Jun 2015
REC opinion
Favourable Opinion