C0311024 Growth Hormone Injections Real World Experience Study
Research type
Research Study
Full title
A MULTICENTER LOW-INTERVENTIONAL STUDY TO EVALUATE AND MONITOR TREATMENT EXPERIENCE WITH WEEKLY GROWTH HORMONE (NGENLA) VERSUS DAILY GROWTH HORMONE INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY
IRAS ID
1008784
Contact name
Adam Schayowitz
Contact email
Sponsor organisation
Pfizer Inc.
Research summary
The purpose of this study is to see if there is a difference in treatment experience between patients using daily growth hormone injections and weekly growth injections in real-world medical settings. “Real-world” setting means that the data come from patients who are being treated in a usual or routine medical practice setting. Approximately 400 children aged between 3 and 16 years with paediatric growth hormone deficiency and treated with either daily growth hormone or Ngenla, a once-weekly growth hormone will be enrolled. Each enrolled patient will be required to use a Smart Sharps Bin™ to collect used needles in real-time, in line with normal practice. The Smart Sharps Bin™ requires a power source and be connected to the network. Every time an injection gets dropped into the bin; this is recorded in real-time. They will also be asked to complete two questionnaires at their regular clinical visits (caregivers will also complete questionnaires). The study period will be 12 months. Five countries in the EU, plus US and Canada will be involved. At the end of the 12 month study period, physicians will be asked to complete a healthcare practitioner survey to assess the physician’s experience of using Ngenla. The Smart Sharps Bin™ will be returned to the clinic at the end of the study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0015
Date of REC Opinion
7 Feb 2024
REC opinion
Further Information Unfavourable Opinion