Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
Completed · Phase 3
Conditions studied: Congenital Hyperinsulinism
In brief
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.
Key facts
- Study ID
- NCT03941236
- Run by
- Zealand Pharma
- People needed
- 42
- Starts
- 2019-05-02
- Expected to finish
- 2026-05-26
- Last updated by the study team
- 2026-08-03
Who can join
Age: 0 and older, up to 13. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Cook Children's Endocrinology and Diabetes Clinic — Fort Worth, Texas, United States
- University Hospital Düsseldorf, Department of Pediatrics — Düsseldorf, Germany
- Otto von Guericke University Magdeburg, Department of Pediatrics — Magdeburg, Germany
- Hadassah Medical Center — Jerusalem, Israel
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom
- Alder Hey Children's Hospital NHS Foundation Trust — Liverpool, United Kingdom
- Great Ormond Street Hospital for Children NHS Foundation Trust — London, United Kingdom
- Manchester University NHS Foundation Trust — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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