Trials / Completed
CompletedNCT03777176
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Zealand Pharma · Industry
- Sex
- All
- Age
- 3 Months – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dasiglucagon | Glucagon analog |
| OTHER | Standard of Care | Standard of care according to site and/or country |
Timeline
- Start date
- 2019-02-07
- Primary completion
- 2020-08-31
- Completion
- 2020-10-05
- First posted
- 2018-12-17
- Last updated
- 2023-12-13
- Results posted
- 2023-12-13
Locations
10 sites across 4 countries: United States, Germany, Israel, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03777176. Inclusion in this directory is not an endorsement.