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Aktiv, aber nicht rekrutierendPHASE3INTERVENTIONELL

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.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE3
Sponsor
Zealand Pharma
Einschreibeziel
42
Starten
02 May 2019
Geschätzte Fertigstellung
31 Dez 2026
Congenital Hyperinsulinism

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Has your child been in a previous dasiglucagon study (ZP4207-17103 or ZP4207-17109)?
  2. Is your child between 5 weeks and 13 years old?
  3. Do your child's doctors believe dasiglucagon is still helpful for their condition?
  4. Does your child have any new health problems or need new medicines that might stop them from joining?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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.

Standorte (10)

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

Häufige Fragen

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.

Wer kann an dieser Studie teilnehmen?

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

Was ist das Hauptziel dieser Studie?

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.

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