Congenital Hyperinsulinism Clinical Trial
Official title:
An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
Verified date | April 2024 |
Source | Zealand Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Zealand Pharma |
United States, Germany, Israel, United Kingdom,
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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