Active not recruitingPHASE3INTERVENTIONAL

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.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Zealand Pharma

Enrolment target

Start

02 May 2019

Estimated completion

31 Dec 2026

Congenital Hyperinsulinism

What is this study about?

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.

Key takeaways

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.

Who may be eligible?

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.

Quick self-check

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?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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.

Potential risks and benefits

Taking part in this study could offer your child the potential benefit of continuing a treatment that might help manage their congenital hyperinsulinism and maintain stable blood sugar levels. It also helps contribute to understanding the long-term effects of dasiglucagon, which could benefit many other children with CHI in the future. However, as with any medication, there are potential risks and side effects, which would have been discussed during the previous studies. These could include reactions at the injection site or other effects on the body. The study team will carefully monitor your child for any adverse reactions. Remember, your participation is completely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting your child's medical care.

Locations (10)

Children's Hospital Colorado
Aurora, United States
The Children's Hospital of Philadelphia
Philadelphia, United States
Cook Children's Endocrinology and Diabetes Clinic
Fort Worth, United States
University Hospital Düsseldorf, Department of Pediatrics
Düsseldorf, Germany
Otto von Guericke University Magdeburg, Department of Pediatrics
Magdeburg, Germany
Hadassah Medical Center
Jerusalem, Israel
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Alder Hey Children's Hospital NHS Foundation Trust
Liverpool, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom

Common questions

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.

Who can join this study?

This study is for children aged 5 weeks to 13 years who have already completed one of two specific previous dasiglucagon studies.

What is the main goal of this study?

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.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.