Status:
COMPLETED
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Lead Sponsor:
Zealand Pharma
Conditions:
Congenital Hyperinsulinism
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
Eligibility Criteria
Inclusion
- Established and documented diagnosis of CHI based on standard of care
- Experiencing ≥3 events of hypoglycemia per week (plasma glucose \[PG\] \<70 mg/dL \[\<3.9 mmol/L\]) according to the investigator's evaluation
- Previously undergone near-total pancreatectomy or being treated with a non-surgical approach, having been evaluated as not eligible for pancreatic surgery
- If somatostatin analogues or sirolimus are used, the therapy should be well established as judged by the investigator, especially when considering their biological half-life
Exclusion
- Previous administration of dasiglucagon
- Known or suspected allergy to the trial drug or related products
- Previous participation (randomization) in this trial
- Circulatory instability requiring supportive medication or presence of pheochromocytoma
- Requires exogenous insulin
- Body weight of \<4 kg (8.8 lbs.)
- Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior to screening
- Known or suspected presence of significant central nervous system disease/injury such that in the investigator's opinion will affect trial participation
- Use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m2 body surface area or equivalent in the 5 days before screening
- Use of anti-inflammatory biological agents, or other immune modulating agents in the 3 months prior to screening
- Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the patient's ability to participate in the trial
- Any recognized clotting or bleeding disorders
- Has participated in an interventional clinical trial (investigational or marketed product) within 3 months of screening or 5 half-lives of the drug under investigation (whichever comes first), or plans to participate in another clinical trial.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03777176
Start Date
February 7 2019
End Date
October 5 2020
Last Update
December 13 2023
Active Locations (10)
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1
Children's Hospital of Colorado
Aurora, Colorado, United States, 13123
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
4
University Hospital Düsseldorf, Department of Pediatrics
Düsseldorf, Germany, 40225