Study of outcomes of switching to Hizentra pre-filled syringes
Research type
Research Study
Full title
An observational study to evaluate physician- and patient-reported outcomes following adoption of Hizentra® pre-filled syringes in subcutaneous immunoglobulin-experienced patients diagnosed with primary immunodeficiency or chronic inflammatory demyelinating polyneuropathy
IRAS ID
253757
Contact name
Stephen Jolles
Contact email
Sponsor organisation
CSL Behring UK Ltd
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This is a UK multicentre, prospective, observational study. This study will be conducted in 3–4 specialist centres across the UK. The study aims to evaluate outcomes following switch from self-administered subcutaneous immunoglobulin (SCIg) (which is called Hizentra) using a pump to manual push-administration using a pre-filled syringe (PFS). As this switch is being made as a part of routine clinical practice, there will be no changes to patient management for the purposes of the study. No additional tests, investigations or visits will be required.
The population for this study is adult patients diagnosed with primary immunodeficiency (PID) or chronic inflammatory demyelinating polyneuropathy (CIDP) who switched to manual push PFS as part of their standard clinical care. It is expected to recruit 40 patients in total.The study will involve 1) evaluation of the time taken per week for patients to infuse their required SCIg dose via pump and via manual push PFS, including all preparation and clean-up time. This will be measured by video recordings (taken by the patient as they prepare and administer their SCIg) from three time points (week 0 [just before the switch to PFS] and at 4 and 12 weeks post-switch). A nurse or physician at the study site will review the video recorded infusion sessions to evaluate timings. They will also look for any procedural deviations and dosing errors. Patients will document brief details of each of the video-recorded infusion sessions (for example the date, start/stop time, volume infused). 2) Assessment of treatment satisfaction through patient-completion of a validated questionnaire at Week 0 and Week 12. 3) Assessment of patient preference through patient-completion of a non-validated bespoke questionnaire at Week 12. 4) Collection of baseline demographic/clinical characteristics and treatment history, and post-switch data from medical records by the clinical care team at each site.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
18/LO/1732
Date of REC Opinion
1 Oct 2018
REC opinion
Favourable Opinion