Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zealand Pharma
Age
0–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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.
Clareo Health | A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
