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ACTIVE NOT RECRUITING
NCT03941236
PHASE3

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

Sponsor: Zealand Pharma

View on ClinicalTrials.gov

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

Interventions

DRUG

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