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NCT03941236
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
Conditions: Congenital Hyperinsulinism
Sex: All
Ages: 5 Weeks – 13 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 42
Sponsor: Zealand Pharma
Location: Children's Hospital Colorado Aurora Colorado
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT03941236). StuddyBuddy aggregates publicly available trial information.