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COMPLETED
NCT02720952
PHASE3

Treatment of Adrenal Insufficiency in Children

Sponsor: Neurocrine UK Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

Infacort®

dry granule formulation of hydrocortisone

Locations (1)

Charité-Universitätsmedizin Berlin, CVK

Berlin, Germany