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Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

NCT03941236

CompletedPhase 3

Sponsor: Zealand Pharma

Conditions: Congenital Hyperinsulinism

Interventions: dasiglucagon

Countries: United States, Germany, Israel, United Kingdom

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 overview

Sex: ALL

Age: 5 Weeks to 13 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (10)

Aurora, Colorado, United States
Philadelphia, Pennsylvania, United States
Fort Worth, Texas, United States
Düsseldorf, Germany
Magdeburg, Germany
Jerusalem, Israel
Glasgow, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Manchester, United Kingdom