drugset / Trial / NCT03941236

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

NCT03941236

Phase 3 Active not recruiting 42 enrolled Zealand Pharma
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-05-02
Primary completion
2025-01-28
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dasiglucagon Peptide 10 ug Subcutaneous
Subject Dasiglucagon Peptide 70 ug Subcutaneous