Clinical Trials Logo

Clinical Trial 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 subcutaneous (SC) infusion in children with CHI.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03941236
Study type Interventional
Source Zealand Pharma
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 1, 2019
Completion date January 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT02021604 - Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma Phase 1
Recruiting NCT04732416 - HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) Phase 2
Completed NCT02937558 - CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism Phase 2
Completed NCT02604485 - A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism Phase 2
Recruiting NCT04205604 - 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism Phase 2
Completed NCT00987168 - Sandostatine® LP and Hyperinsulinism Phase 2
Completed NCT00897676 - Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity Phase 1/Phase 2
Completed NCT03042416 - 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety Phase 3
Completed NCT04172441 - Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism Phase 2/Phase 3
Recruiting NCT04706910 - 18F-DOPA II - PET Imaging Optimization Phase 3
Recruiting NCT06208215 - RZ358 Treatment for Congenital Hyperinsulinism Phase 3
Completed NCT03777176 - A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism Phase 3
Recruiting NCT03768518 - GLP-1 Receptor Expression in CHI
Completed NCT04538989 - An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism Phase 2
Completed NCT01070758 - Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy Phase 4
Completed NCT00674440 - Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism Phase 2
Terminated NCT00835328 - Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia Phase 1/Phase 2
Completed NCT00571324 - Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism Phase 1/Phase 2
Withdrawn NCT03053284 - Pasireotide in Hyperinsulinemic Hypoglycemia Phase 2
No longer available NCT02533219 - Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia