drugset / Trial / NCT03941236
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dasiglucagon | Peptide | 10 ug | Subcutaneous |
| Subject | Dasiglucagon | Peptide | 70 ug | Subcutaneous |