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Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
Sponsor: Zealand Pharma
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 or ZP4207-17109 (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.
Official title: An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
Key Details
Gender
All
Age Range
5 Weeks - 13 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2019-05-02
Completion Date
2026-12-31
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
dasiglucagon
Glucagon analog
Locations (10)
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