ZP4207-106 A Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

This is an open-label, multinational, multicentre, long-term safety and efficacy trial in patients with CHI who completed either ZP4207-17103 or ZP4207-17109 (the ‘lead-in trials’). Informed consent (and assent as applicable) for participation in this trial will be obtained from eligible patients. Eligible patients will continue with dasiglucagon at the dose level reached at the end of their participation in the lead-in trial, with allowance for further dasiglucagon dose adjustments and changes to CHI standard of care (SOC) medications in order to optimise the treatment of the individual patient.
To use a minimally invasive yet objective method of assessing the frequency of hypoglycaemia, patients will be required to wear a continuous glucose monitoring (CGM) device, and families will also be asked to perform self-monitoring of blood glucose (SMBG).
The end-of-treatment visit from the lead-in trial will serve as the baseline visit for the present trial, and any post-treatment follow-up scheduled for patients in the lead-in trial will be redundant if they are enrolled in the present trial by the time of the scheduled follow-up visit.
Patients will be seen at Month 1, 3, and 6 and every 3 months thereafter. Details on dasiglucagon and other relevant data will be collected in an electronic diary at specified intervals and reviewed by site staff. Patients will be allowed to remain in the trial until approval of dasiglucagon