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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasiglucagon open-label | Experimental | Dasiglucagon treatment as an SC infusion in the dose range 10-70 μg/h titrated individually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasiglucagon | Drug | Glucagon analog |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Nasogastric (NG) tube or gastrostomy removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Information Desk | Zealand Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045-7106 | United States | ||
| The Children's Hospital of Philadelphia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2025 | Sep 11, 2025 |
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Time to removal of NG tube or gastrostomy |
| Baseline through treatment completion, up to 3 years |
| Pancreatic surgery | Time to pancreatic surgery (sub-total or total pancreatectomy) | Baseline through treatment completion, up to 3 years |
| Time in hypoglycemia | Continuous glucose monitoring (CGM) percent time <70 mg/dL (3.9 mmol/L) | Baseline through treatment completion, up to 3 years |
| 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 |
| 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 |
| Gastric carbohydrate administrations | Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia | Baseline through treatment completion, up to 3 years |
| 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 |
| 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 |
| 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 |
| 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 |
| Somatostatin analog dose | Reduction in somatostatin analog dose from start of lead-in trial | Baseline through treatment completion, up to 3 years |
| 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 |
| 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 |
| 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 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Cook Children's Endocrinology and Diabetes Clinic | Fort Worth | Texas | 76104-2710 | United States |
| University Hospital Düsseldorf, Department of Pediatrics | Düsseldorf | 40225 | Germany |
| Otto von Guericke University Magdeburg, Department of Pediatrics | Magdeburg | 39120 | Germany |
| Hadassah Medical Center | Jerusalem | 9765422 | Israel |
| NHS Greater Glasgow and Clyde | Glasgow | United Kingdom |
| Alder Hey Children's Hospital NHS Foundation Trust | Liverpool | United Kingdom |
| Great Ormond Street Hospital for Children NHS Foundation Trust | London | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | United Kingdom |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2024 | Sep 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D044903 | Congenital Hyperinsulinism |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007003 | Hypoglycemia |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
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