A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency
This research study is about finding a possibly easier way for children with growth hormone deficiency to receive their treatment. Currently, many children need daily injections of growth hormone. This study is testing a new medication called Sogroya, which is designed to be given just once a week, against the standard daily treatment, Norditropin. Researchers want to see if Sogroya helps children grow taller just as effectively as the daily injections over a year. They will also be carefully checking for any side effects or changes in health markers like blood sugar. The aim is to understand if a once-weekly injection could be a safe and effective option, potentially making treatment more convenient for children and their families.
At a glance
What is this study about?
This study is designed for children who have a condition called growth hormone deficiency. This means their bodies don't make enough growth hormone, which is important for them to grow and develop properly. Currently, many children with this condition need to have an injection every day to replace the missing hormone. This can be a bit of a challenge for children and their families.
The researchers are looking into a new medication called Sogroya. The exciting thing about Sogroya is that it's designed to be given only once a week, rather than every day. They want to find out if this once-a-week treatment is just as good at helping children grow taller as the traditional daily treatment, which in this study is called Norditropin. They will be measuring how much children grow over about a year to compare the two.
Besides checking how well the treatments help children grow, the study will also carefully look at how safe they are. This means checking for any side effects and monitoring important health signs, like blood sugar levels, over a longer period. The goal is to see if a weekly injection could be a safe and effective alternative, which might make managing growth hormone deficiency a bit simpler for children and their families.
Key takeaways
- Compares a new weekly growth hormone injection (Sogroya) with current daily treatment (Norditropin).
- Aims to see if weekly treatment helps children grow as well as daily treatment.
- Carefully checks for safety and any side effects.
- Main study period is about one year, with longer follow-up.
- Could offer a more convenient treatment option for children.
- Participation involves regular clinic visits and at-home injections.
Who may be eligible?
This study is looking for children who have been diagnosed with growth hormone deficiency. This is a condition where a child's body doesn't produce enough of the hormone needed for growth.
Generally, if your child has been diagnosed with this condition and meets other specific medical criteria set by the doctors running the study, they might be able to take part. This study welcomes both boys and girls of all ages who meet the requirements. The study team will review your child's medical history to make sure the study is a good fit for them.
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.
- Has your child been diagnosed with growth hormone deficiency?
- Is your child currently receiving growth hormone treatment, or needing to start?
- Are you able to attend regular clinic visits with your child?
- Are you comfortable with the idea of your child receiving injections?
- Are you able to commit to the study's duration, potentially several years?
What does participation involve?
If your child takes part in this study, they would be involved for quite a while, with the main part lasting about a year, and some checks continuing for up to four years. During this time, they would either receive the new weekly Sogroya injection or the standard daily Norditropin injection. Which treatment they receive would be decided by chance, like flipping a coin.
Throughout the study, your child would have regular visits to the clinic. These visits would involve doctors measuring their height, checking their general health, taking blood samples to monitor their progress and safety, and generally making sure they are well. The injections would typically be given at home by you after you've been shown how to do it, or by a healthcare professional. There will be careful follow-up to make sure everything is going smoothly.
Potential risks and benefits
Locations (8)
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedSlovenia
- —UnverifiedPoland
- —UnverifiedAustria
- —UnverifiedFrance
- —UnverifiedLatvia
Common questions
What is growth hormone deficiency?
It's a condition where a child's body doesn't produce enough growth hormone, which can affect their height and development.
What is the new medication being tested?
The new medication is called Sogroya, and researchers are studying if it can be given once a week instead of daily.
Will my child definitely get the new weekly injection?
No, your child will be randomly assigned to either receive the new weekly Sogroya or the standard daily Norditropin treatment.
How long will my child need to be in the study?
The main part of the study lasts about a year, but follow-up checks could continue for up to four years.
What happens during clinic visits?
Clinic visits will involve height measurements, health checks, and blood tests to monitor your child's progress and safety.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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