MedTrace Logo

A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

NCT03777176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-12-13

Study results available
· View outcomes & findings →

Summary

The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

Dasiglucagon

Glucagon analog

OTHER

Standard of Care

Standard of care according to site and/or country

Sponsors & Collaborators

Principal Investigators

  • Charlotte Teglman Schioeler · Zealand Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-08-31
Completion
2020-10-05
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 NCT03777176 on ClinicalTrials.gov