CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Infacort®drug
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.

Search/NCT02720952
NCT02720952Phase 3Completed
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A Phase 3 Open-label Study of Infacort® in Neonates, Infants and Children Less Than 6 Years of Age With Adrenal Insufficiency

Neurocrine UK Limited·interventional·Posted Mar 28, 2016·Updated May 4, 2022

In Brief

A Phase 3 clinical trial evaluating Infacort® for Adrenal Insufficiency. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The study will be conducted in a total of 24 subjects before their 6th birthday, requiring replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or hypopituitarism. The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged between 2 and \< 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to \<2 years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only if again no safety concerns emerge, then 6 neonates aged from birth to \<28 days will be enrolled (Cohort 3). The decision to continue after each cohort will be based on the recommendation of an Independent Data Monitoring Committee (IDMC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdrenal Insufficiency
CountriesGermany
CollaboratorsTreatment of Adrenal Insufficiency in Neonates consortium (TAIN)

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 28, 2016
Enrollment StartMar 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.3 years ago

Interventions

Infacort®drug

dry granule formulation of hydrocortisone