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Clinical trial

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

ID
Name
ZP4207-17106
Description
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.
Trial arms
Trial start
2019-05-01
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
dasiglucagon
Glucagon analog
Arms:
Dasiglucagon open-label
Other names:
ZP4207
Size
44
Primary endpoint
Adverse Events
Baseline through treatment completion, up to 3 years
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2024-04-08

1 organization

1 product

1 indication

Organization
Zealand Pharma
Product
dasiglucagon
Indication
Congenital Hyperinsulinism