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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Hyperinsulinism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dasiglucagon open-label

Dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care

Group Type EXPERIMENTAL

dasiglucagon

Intervention Type DRUG

Glucagon analog

Interventions

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dasiglucagon

Glucagon analog

Intervention Type DRUG

Other Intervention Names

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ZP4207

Eligibility Criteria

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Inclusion Criteria

* Completed treatment in either Trial ZP4207-17103 or ZP4207-17109
* Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial)

Exclusion Criteria

* The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No