A Study of Romiplostim Self-Administration After Use of HAT Materials.
Research type
Research Study
Full title
A cross-sectional study of patients with immune thrombocytopenic purpura and caregivers to estimate the proportion who administer romiplostim correctly after receipt of home administration training materials.
IRAS ID
161738
Contact name
Marion-Louise Taylor
Contact email
Sponsor organisation
Amgen Ltd
Research summary
Registration of Nplate® (romiplostim) in the European Union has been extended to allow for the possible administration of it by patients themselves or their lay caregivers in their home environment. To minimize the risk of potential medication errors from self-administration, a Home Administration Training (HAT) pack was prepared to support the training of patients and their caregivers.
This study is addressed to patients suffering from immune thrombocytopenic purpura (ITP) who are currently treated with Nplate®, or their lay caregivers new to administering Nplate®. The purpose of this study is to learn more about the
use of the Home Administration Training pack for the administration of Nplate® and to find out how many adult participants administer Nplate® correctly after being trained using Home Administration Training pack.
This is a non-interventional study. This means that study participants will not be required to change their therapy, have any experimental medication or undergo any extra procedures or tests. All data collected in this study will come from
routine clinical care.
This study will involve direct observation by a healthcare professional of how study participants administer Nplate®. This direct observation will take place during a routine visit 4 weeks after Home Administration Training pack training.
Each participant will be asked to give informed consent to this study. About 40 participants are expected to take part in this study within European Union.
This study will help identify possible improvements to the Home Administration Training pack training and will serve as an early indicator of the likelihood of medication errors associated with self-administration of Nplate®.
The study is funded by Amgen. The start of study participants enrollment is planned for August 2014. All data is to be collected by June 2016, and the final report is to be released by December 2016.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1473
Date of REC Opinion
11 Aug 2014
REC opinion
Favourable Opinion