Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
This study is a long-term trial for children with a rare condition called congenital hyperinsulinism (CHI). In CHI, the body makes too much insulin, leading to dangerously low blood sugar. This study is for children aged 5 weeks to 13 years who have already participated in one of two specific earlier studies (ZP4207-17103 or ZP4207-17109) looking at a medicine called dasiglucagon. The main goal is to find out if dasiglucagon, given as an infusion under the skin, is safe for these children over a longer period. It also checks how well the treatment continues to help manage their blood sugar. All children involved will receive the dasiglucagon treatment, and doctors will carefully monitor their health and progress.
במבט חטוף
על מה המחקר הזה?
This study is about a condition called congenital hyperinsulinism, often shortened to CHI. In children with CHI, their body makes too much insulin – the hormone that controls blood sugar – which can lead to blood sugar levels becoming dangerously low. This can cause various health problems if not well-managed.
Doctors are exploring a treatment called dasiglucagon. This medicine helps to increase blood sugar when levels drop too low. This particular study is an 'extension trial,' meaning it follows up on children who have already taken part in previous studies of dasiglucagon. The main aim is to gather more information about how safe dasiglucagon is when used for a longer time.
By continuing to observe these children, doctors hope to learn more about the long-term benefits and any potential side effects of dasiglucagon. This information is very important to help children with CHI live healthier lives and better manage their condition in the future.
נקודות עיקריות
- This study is for children with a condition called congenital hyperinsulinism (CHI).
- It tests the long-term safety and effectiveness of a medicine called dasiglucagon.
- Only children who have been in previous specific dasiglucagon studies can join.
- The study aims to help children manage their blood sugar and improve future treatments.
- Participation is voluntary, and your child's health will be closely monitored.
מי עשוי להיות זכאי?
This study is specifically designed for children who have already completed one of two previous studies involving dasiglucagon: studies ZP4207-17103 or ZP4207-17109. This means your child would have already received this treatment and been closely monitored.
To join this long-term study, the doctors involved must believe that dasiglucagon continues to be helpful for your child, and that the benefits outweigh any potential risks. They will look at how the treatment has affected your child's blood sugar, how well they tolerated it, and any side effects they might have experienced in the earlier study.
Your child cannot join this study if they developed any new health problems, needed new medicines that were not allowed in the previous studies, or if their doctor feels there are other reasons why taking part would not be safe or suitable for them.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Has your child been in a previous dasiglucagon study (ZP4207-17103 or ZP4207-17109)?
- Is your child between 5 weeks and 13 years old?
- Do your child's doctors believe dasiglucagon is still helpful for their condition?
- Does your child have any new health problems or need new medicines that might stop them from joining?
מה כרוך בהשתתפות?
If your child is eligible and you decide to take part, they will continue to receive dasiglucagon as an infusion given under the skin. As this is an extension study, the exact details of visits and assessments will be tailored to what's needed for long-term monitoring, building upon what was learned in the previous studies. This will involve regular check-ups with the study doctors and nurses, where they will monitor your child's blood sugar levels, overall health, and any side effects. You will be given clear instructions on how to administer the dasiglucagon at home and what to do in case of any concerns. The total duration for how long each child will stay in this study has not been specified, but it's designed to be a longer-term observation.
סיכונים ותועלות פוטנציאליים
מיקומים (10)
- בית החולים לילדים קולורדומיקוד מאומתאורורה, ארצות הברית
- The Children's Hospital of Philadelphiaמיקוד מאומתפילדלפיה, ארצות הברית
- Cook Children's Endocrinology and Diabetes Clinicמיקוד מאומתFort Worth, United States
- University Hospital Düsseldorf, Department of Pediatricsמיקוד מאומתדיסלדורף, גרמניה
- Otto von Guericke University Magdeburg, Department of Pediatricsמיקוד מאומתמגדבורג, גרמניה
- Hadassah Medical Centerמיקוד מאומתירושלים, ישראל
- NHS Greater Glasgow and Clydeמיקוד מאומתגלאזגו, הממלכה המאוחדת
- Alder Hey Children's Hospital NHS Foundation Trustמיקוד מאומתLiverpool, United Kingdom
- Great Ormond Street Hospital for Children NHS Foundation Trustמיקוד מאומתלונדון, הממלכה המאוחדת
- קרן שירותי הבריאות הלאומית של אוניברסיטת מנצ'סטרמיקוד מאומתמנצ'סטר, הממלכה המאוחדת
שאלות נפוצות
What is congenital hyperinsulinism (CHI)?
CHI is a rare condition where the body makes too much insulin, which causes very low blood sugar levels.
What is dasiglucagon?
Dasiglucagon is a medicine being tested that helps to raise blood sugar levels when they get too low.
מי יכול להצטרף למחקר זה?
This study is for children aged 5 weeks to 13 years who have already completed one of two specific previous dasiglucagon studies.
מה המטרה העיקרית של המחקר הזה?
The main goal is to find out if dasiglucagon is safe for long-term use in children with CHI.
Will my child definitely get the study medication?
Yes, all children in this extension study will receive dasiglucagon.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
דיון קהילתי
מופעל על ידי הפורום שלנו ב community.patient.info. אנא היו מכבדים — זה אינו ייעוץ רפואי.