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Treatment of Adrenal Insufficiency in Children
Sponsor: Neurocrine UK Limited
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).
Official title: A Phase 3 Open-label Study of Infacort® in Neonates, Infants and Children Less Than 6 Years of Age With Adrenal Insufficiency
Key Details
Gender
All
Age Range
1 Week - 6 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2015-03
Completion Date
2016-07
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Infacort®
dry granule formulation of hydrocortisone
Locations (1)
Charité-Universitätsmedizin Berlin, CVK
Berlin, Germany