A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
This study is designed to carefully watch children who are being treated with a medicine called somapacitan for a condition called growth hormone deficiency. Doctors want to understand how safe this medicine is and how well it works over many years in children. They will be looking at important health information as part of regular check-ups. The study involves 400 children who are already receiving somapacitan and are registered in a special database called GloBE-Reg. The total study will last for 10 years, which includes a time to gather new participants and then a longer time to follow up on their health. This helps ensure we learn as much as possible about the medicine's long-term effects.
At a glance
What is this study about?
This study is all about understanding the long-term effects of a medicine called somapacitan, which is used to treat children who have growth hormone deficiency. Growth hormone deficiency means a child's body doesn't produce enough growth hormone, which helps them grow and develop normally. Somapacitan is a treatment designed to help with this.
The main goal of this research is to check the safety of somapacitan over many years and to see how it affects a child's health and development during this time. The doctors involved aren't giving out new medicine for this study; instead, they are observing children who are already being treated with somapacitan as part of their usual medical care. This kind of study helps us learn more about how medicines work in real-life situations.
The information gathered from this study will help healthcare professionals understand more about somapacitan, especially its long-term impact. This is important because it means doctors can make the best decisions about treatment for children with growth hormone deficiency in the future, always striving for the safest and most effective care.
Key takeaways
- This study focuses on the long-term safety of somapacitan in children.
- It's for children already treated for growth hormone deficiency.
- Participation involves sharing information from routine medical appointments.
- The study aims to follow children for up to 10 years.
- No new medicine is given for the purpose of this study.
- The information helps improve future care for children with growth hormone deficiency.
Who may be eligible?
To be part of this study, children must already be receiving a medicine called somapacitan for growth hormone deficiency, as prescribed by their doctor, and according to what's common practice in the UK. They must also have a clear diagnosis of growth hormone deficiency.
Children can be male or female, but they need to be under 18 years old when they (or their parents/guardians) agree to take part in the study. This ensures the study focuses on the treatment effects in younger individuals.
However, children cannot join if they currently have cancer or are receiving treatment for cancer that they had before. This is because these conditions could affect the study results or make it harder to understand how effective or safe somapacitan is for growth hormone deficiency.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child currently taking somapacitan for growth hormone deficiency?
- Does my child have a confirmed diagnosis of growth hormone deficiency?
- Is my child under 18 years old?
- Does my child currently NOT have cancer or treatment for cancer?
What does participation involve?
If a child takes part in this study, it's mostly about collecting information from their regular doctor visits. They won't usually have extra appointments just for the study. Doctors will record details about their health, such as how they are growing and any health changes, as part of their usual check-ups while they are on somapacitan. There are no new medicines given for this study; it's about watching what happens when children are treated with somapacitan as part of their normal care.
The study plans to follow children for up to 10 years. This long follow-up allows researchers to understand the long-term safety and effects of somapacitan. You or your child's doctor will be providing information that helps build a complete picture over time.
Potential risks and benefits
Locations (1)
- University of GlasgowVerified postcodeGlasgow, United Kingdom
Common questions
What is somapacitan?
Somapacitan is a medicine used to treat children who don't produce enough growth hormone, helping them to grow like other children.
Will my child get new medicine in this study?
No, this study only involves children who are already taking somapacitan as part of their regular treatment. No new medicine is given for the study.
How long will my child be in the study?
The study plans to follow children for up to 10 years, gathering information from their regular doctor's visits over this long period.
What information will be collected?
Doctors will collect information about your child's health and development, as they normally would during routine check-ups while your child is on somapacitan.
Can we stop participating at any time?
Yes, you can choose to withdraw your child from the study at any point without it affecting their medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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