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

NCT03941236 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

dasiglucagon

Glucagon analog

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Information Desk · Zealand Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Weeks
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2025-01-28
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Israel
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941236 on ClinicalTrials.gov