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

Zealand Pharma

Status and phase: Active, not recruiting; Phase 3

Conditions: Congenital Hyperinsulinism

Treatments: Drug: dasiglucagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT03941236

ZP4207-17106

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 5 weeks to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Dasiglucagon open-label

Experimental group

Description:

Dasiglucagon treatment as an SC infusion in the dose range 10-70 μg/h titrated individually +/- standard of care

Treatment:

Drug: dasiglucagon