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

  • Clinicaltrials.gov identifier

    NCT03941236

  • Recruitment Status

    Enrolling by invitation

  • First Posted

    May 7, 2019

  • Last update posted

    July 7, 2020

Study Description

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:Congenital Hyperinsulinism
  • Intervention/Treatment: Drug: dasiglucagon
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • 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 2019
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: March 2022

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Adverse Events [ Time Frame: Baseline through trial completion, up to 2 years ]
    Number of adverse events occurring in each 3-month period
  • Secondary Outcome Measures: 1. Pancreatic surgery [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Time to pancreatic surgery (sub-total or total pancreatectomy)
  • 2. Time in hypoglycemia [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Percent time in hypoglycemia (<70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring
  • 3. Hypoglycemia events [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Number of hypoglycemic events (PG <70 mg/dL [3.9 mmol/L]) as detected by self-monitored plasma glucose
  • 4. Amount of gastric carbohydrates administered to treat hypoglycemia [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia
  • 5. Nasogastric (NG) tube or gastrostomy removal [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Time to removal of NG tube or gastrostomy
  • 6. Clinically significant episodes of hypoglycemia [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Incidence of clinically significant episodes of hypoglycemia, defined as <54 mg/dL (3.0 mmol/L) for 15 minutes or more, as measured by continous glucose monitoring
  • 7. Gastric carbohydrate administrations [ Time Frame: Baseline through treatment completion, up to 2 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 2 years ]
    Number of nightly gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia
  • 9. Extent of hypoglycemia [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring
  • 10. Diazoxide dose [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Change in diazoxide dose in mg/kg body weight/day from start of lead-in trial
  • 11. Somatostatin analog dose [ Time Frame: Baseline through treatment completion, up to 2 years ]
    Change in somatostatin analog dose from start of lead-in trial

Eligibility Criteria

  • Ages Eligible for Study: 6 to 13 Weeks (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.

Contacts and Locations

Contacts

Locations

United States, Colorado
Children's Hospital of Colorado
Aurora

United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia

United States, Texas
Cook Children's Medical Center
Fort Worth

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

Sponsors and Collaborators

Zealand Pharma

Investigators

Study Director: Benedikte Bandak Zealand Pharma

More Information

  • Responsible Party: Zealand Pharma
  • ClinicalTrials.gov Identifier: NCT03941236 History of Changes
  • Other Study ID Numbers: ZP4207-17106
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: July 7, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Congenital Hyperinsulinism Hyperinsulinism