Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Con… (NCT03941236) | Clinical Trial Compass
CompletedPhase 3
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
United States, Germany, Israel42 participantsStarted 2019-05-02
Plain-language summary
This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 (NCT04172441) or ZP4207-17109 (NCT03777176) (defined as lead-in trials).
The primary objective is to evaluate the long-term safety of dasiglucagon administered as a subcutaneous (SC) infusion in children with CHI.
Who can participate
Age range
5 Weeks – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Completed treatment in either Trial ZP4207-17103 or ZP4207-17109
* Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial)
Exclusion Criteria:
* The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a long-term extension trial focused on tracking adverse events in children, what kinds of safety concerns or side effects with dasiglucagon have already shown up in the earlier studies that led to this extension?
2This trial is in Phase 3 and is no longer recruiting — does that mean my child has missed the chance to enroll, and are there any similar active trials we could look into instead?
3Because the main thing being measured here is long-term safety rather than proving the drug works better than existing options, what does that tell us about how confident doctors currently are in dasiglucagon's effectiveness for congenital hyperinsulinism?
4How does dasiglucagon compare to the current standard treatments my child is already on, and would joining an extension trial like this require us to change or stop those existing treatments?
5Given that this is a long-term study in children, what would the ongoing commitment look like in terms of clinic visits, monitoring, and travel, and how might that affect our family's day-to-day life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: Baseline through treatment completion, up to 3 years