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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03941236
Other study ID # ZP4207-17106
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 1, 2019
Est. completion date January 1, 2025

Study information

Verified date April 2024
Source Zealand Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 subcutaneous (SC) infusion in children with CHI.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Weeks to 13 Years
Eligibility 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.

Study Design


Intervention

Drug:
dasiglucagon
Glucagon analog

Locations

Country Name City State
Germany University Hospital Düsseldorf, Department of Pediatrics Düsseldorf
Germany Otto von Guericke University Magdeburg, Department of Pediatrics Magdeburg
Israel Hadassah Medical Center Jerusalem
United Kingdom NHS Greater Glasgow and Clyde Glasgow
United Kingdom Alder Hey Children's Hospital NHS Foundation Trust Liverpool
United Kingdom Great Osmond Street Hospital for Children NHS Foundation Trust London
United Kingdom Central Manchester University Hospital NHS Foundation Trust Manchester
United States Children's Hospital of Colorado Aurora Colorado
United States Cook Children's Medical Center Fort Worth Texas
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Zealand Pharma

Countries where clinical trial is conducted

United States,  Germany,  Israel,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis Baseline through treatment completion, up to 3 years
Secondary Amount of gastric carbohydrates administered to treat hypoglycemia Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia Baseline through treatment completion, up to 3 years
Secondary Nasogastric (NG) tube or gastrostomy removal Time to removal of NG tube or gastrostomy Baseline through treatment completion, up to 3 years
Secondary Pancreatic surgery Time to pancreatic surgery (sub-total or total pancreatectomy) Baseline through treatment completion, up to 3 years
Secondary Time in hypoglycemia Continuous glucose monitoring (CGM) percent time <70 mg/dL (3.9 mmol/L) Baseline through treatment completion, up to 3 years
Secondary Hypoglycemia episodes Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more Baseline through treatment completion, up to 3 years
Secondary Clinically significant episodes of hypoglycemia Rate of clinically significant CGM-detected hypoglycemia episodes <54 mg/dL (3.0 mmol/L) for 15 minutes or more Baseline through treatment completion, up to 3 years
Secondary Gastric carbohydrate administrations Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia Baseline through treatment completion, up to 3 years
Secondary Nightly gastric carbohydrate administrations Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia Baseline through treatment completion, up to 3 years
Secondary Extent of hypoglycemia Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring (CGM) Baseline through treatment completion, up to 3 years
Secondary Extent of clinically significant hypoglycemia Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 54 mg/dL [3.0 mmol/L]) as measured by continous glucose monitoring (CGM) Baseline through treatment completion, up to 3 years
Secondary Diazoxide dose Reduction in diazoxide dose in mg/kg body weight/day from start of lead-in trial Baseline through treatment completion, up to 3 years
Secondary Somatostatin analog dose Reduction in somatostatin analog dose from start of lead-in trial Baseline through treatment completion, up to 3 years
Secondary Prescribed amount of continuous gastric carbohydrate administration Change in total amount of prescribed continuous gastric carbohydrate administration from start of lead-in trial (g/day) Baseline through treatment completion, up to 3 years
Secondary Prescribed duration of continuous gastric carbohydrate administration Change in prescribed duration of infusion of continuous gastric carbohydrate administration from start of lead-in trial (h/day) Baseline through treatment completion, up to 3 years
Secondary Prescribed duration of nightly continuous gastric carbohydrate administration Change in prescribed duration of infusion of nightly (8 pm - 8 am) continuous gastric carbohydrate administration from start of lead-in trial (h/day) Baseline through treatment completion, up to 3 years
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