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

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ClinicalTrials.gov Identifier: NCT03941236
Recruitment Status : Enrolling by invitation
First Posted : May 7, 2019
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Brief 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.


Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Drug: dasiglucagon Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dasiglucagon open-label
Dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care
Drug: dasiglucagon
Glucagon analog
Other Name: ZP4207




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Baseline through treatment completion, up to 3 years ]
    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


Secondary Outcome Measures :
  1. Amount of gastric carbohydrates administered to treat hypoglycemia [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia

  2. Nasogastric (NG) tube or gastrostomy removal [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Time to removal of NG tube or gastrostomy

  3. Pancreatic surgery [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Time to pancreatic surgery (sub-total or total pancreatectomy)

  4. Time in hypoglycemia [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Continuous glucose monitoring (CGM) percent time <70 mg/dL (3.9 mmol/L)

  5. Hypoglycemia episodes [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more

  6. Clinically significant episodes of hypoglycemia [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Rate of clinically significant CGM-detected hypoglycemia episodes <54 mg/dL (3.0 mmol/L) for 15 minutes or more

  7. Gastric carbohydrate administrations [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

  8. Nightly gastric carbohydrate administrations [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

  9. Extent of hypoglycemia [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring (CGM)

  10. Extent of clinically significant hypoglycemia [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 54 mg/dL [3.0 mmol/L]) as measured by continous glucose monitoring (CGM)

  11. Diazoxide dose [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Reduction in diazoxide dose in mg/kg body weight/day from start of lead-in trial

  12. Somatostatin analog dose [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Reduction in somatostatin analog dose from start of lead-in trial

  13. Prescribed amount of continuous gastric carbohydrate administration [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Change in total amount of prescribed continuous gastric carbohydrate administration from start of lead-in trial (g/day)

  14. Prescribed duration of continuous gastric carbohydrate administration [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Change in prescribed duration of infusion of continuous gastric carbohydrate administration from start of lead-in trial (h/day)

  15. Prescribed duration of nightly continuous gastric carbohydrate administration [ Time Frame: Baseline through treatment completion, up to 3 years ]
    Change in prescribed duration of infusion of nightly (8 pm - 8 am) continuous gastric carbohydrate administration from start of lead-in trial (h/day)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941236


Locations
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United States, Colorado
Children's Hospital of Colorado
Aurora, Colorado, United States, 13123
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Germany
University Hospital Düsseldorf, Department of Pediatrics
Düsseldorf, Germany, 40225
Otto von Guericke University Magdeburg, Department of Pediatrics
Magdeburg, Germany, 39120
Israel
Hadassah Medical Center
Jerusalem, Israel, 9765422
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 Kingdom
Sponsors and Collaborators
Zealand Pharma
Investigators
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Study Director: Have Andersen Aliu, MSc, PhD Zealand Pharma
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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03941236    
Other Study ID Numbers: ZP4207-17106
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Hyperinsulinism
Nesidioblastosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia