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NCT04172441 · ClinicalTrials.gov registry record · Phase 2
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
A Phase 2 study of Congenital Hyperinsulinism, sponsored by Zealand Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 6
- Study locations
NCT04172441: Completed Phase 2 study of Congenital Hyperinsulinism, sponsored by Zealand Pharma.
NCT04172441 is a Phase 2 study of Congenital Hyperinsulinism that has completed, run by Zealand Pharma. The registered enrollment target is 12 participants, below the 77-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04172441, a Phase 2 study of Congenital Hyperinsulinism, has completed, sponsored by Zealand Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 6
- Study locations
Study Summary
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
Primary Outcome
Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG dasiglucagon
Study Locations (6)
Other
- University Children's Hospital - Düsseldorf
- University Hospital, Magdeburg - Magdeburg
- Hadassah Medical Center - Jerusalem
- Manchester University NHS Foundation Trust - Manchester
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-06-19 |
| Est. Completion | 2022-03-07 |
| Phase | Phase 2 |
What the finished NCT04172441 record still lists
NCT04172441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 77-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04172441 lists 6 locations in 3 states (Other, Pennsylvania, Texas).
Frequently Asked Questions
What is clinical trial NCT04172441 about?
NCT04172441 is a clinical study titled "Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism". The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
What is the current status of trial NCT04172441?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2020-06-19. Estimated completion is 2022-03-07.
What conditions does trial NCT04172441 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism.
What interventions are being tested in trial NCT04172441?
The interventions under investigation include: Placebo (DRUG), dasiglucagon (DRUG).
Who is sponsoring clinical trial NCT04172441?
This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04172441 being conducted?
This trial has 6 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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