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NCT03941236 · ClinicalTrials.gov registry record · Phase 3
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
A Phase 3 study of Congenital Hyperinsulinism, sponsored by Zealand Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
- 10
- Study locations
NCT03941236: Active Phase 3 study of Congenital Hyperinsulinism, sponsored by Zealand Pharma.
NCT03941236 is a Phase 3 study of Congenital Hyperinsulinism that is active but no longer recruiting, run by Zealand Pharma. The registered enrollment target is 42 participants, below the 72-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (42% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03941236, a Phase 3 study of Congenital Hyperinsulinism, is active but no longer recruiting, sponsored by Zealand Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
- 10
- Study locations
Study 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 a subcutaneous (SC) infusion in children with CHI.
Primary Outcome
Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis
Conditions Studied
Interventions
- DRUG dasiglucagon
Study Locations (10)
Other
- University Hospital Düsseldorf, Department of Pediatrics - Düsseldorf
- Otto von Guericke University Magdeburg, Department of Pediatrics - Magdeburg
- Hadassah Medical Center - Jerusalem
- NHS Greater Glasgow and Clyde - Glasgow
- Alder Hey Children's Hospital NHS Foundation Trust - Liverpool
- Great Ormond Street Hospital for Children NHS Foundation Trust - London
- Manchester University NHS Foundation Trust - Manchester
Colorado
- Children's Hospital Colorado - Aurora
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Texas
- Cook Children's Endocrinology and Diabetes Clinic - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-05-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03941236 still lists
NCT03941236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 72-participant average among 7 other Congenital Hyperinsulinism trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Congenital Hyperinsulinism appearing as the primary indexed condition, and to 1 intervention - of which dasiglucagon is the first listed.
NCT03941236 lists 10 locations in 4 states (Other, Colorado, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT03941236 about?
NCT03941236 is a clinical study titled "Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism". 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...
What is the current status of trial NCT03941236?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2019-05-02. Estimated completion is 2026-12-31.
What conditions does trial NCT03941236 study?
This clinical trial studies the following conditions: Congenital Hyperinsulinism.
What interventions are being tested in trial NCT03941236?
The interventions under investigation include: dasiglucagon (DRUG).
Who is sponsoring clinical trial NCT03941236?
This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03941236 being conducted?
This trial has 10 study locations across Colorado, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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