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Active Not Recruiting NCT03941236

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

Conditions: Congenital Hyperinsulinism

Sex: All
Ages: 5 Weeks – 13 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 42
Sponsor: Zealand Pharma

Location: Children's Hospital Colorado Aurora Colorado

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 (NCT04172441) or ZP4207-17109 (NCT03777176) (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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03941236). StuddyBuddy aggregates publicly available trial information.