At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 5 enrolled
Drug / intervention
Glucagon +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Proof-of-Concept Study of CSI-Glucagon™ (Continuous Subcutaneous Glucagon Infusion) to Prevent Hypoglycemia With Lower Intravenous Glucose Infusion Rates in Children up to One Year of Age With Congenital Hyperinsulinism
In Brief
A Phase 2 clinical trial evaluating Glucagon and Placebo for Congenital Hyperinsulinism. Completed, enrolled 5 participants across 5 sites.
Detailed Summary
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose infusion rates in children \< 1 year of age with congenital hyperinsulinism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Hyperinsulinism
CountriesUnited States
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionSep 2018
Study CompletionOct 2018
TodayJul 2026
First PostedOct 18, 2016
Enrollment StartOct 1, 2016
Primary CompletionSep 1, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.7 years ago
Interventions
Glucagondrug
Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide
Placeboother
Isotonic saline