Active — Not RecruitingPhase 3

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

United States, Germany42 participantsStarted 2019-05-02

Plain-language 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.

Who can participate

Age range5 Weeks – 13 Years

SexALL

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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.

What they're measuring

Adverse Events

Timeframe: Baseline through treatment completion, up to 3 years

Trial details

NCT IDNCT03941236

SponsorZealand Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-28

View on ClinicalTrials.gov More Congenital Hyperinsulinism trials