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Extension Study for Patients Entered Into Study Infacort 003
Sponsor: Neurocrine UK Limited
Summary
A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to take part in Infacort 004.
Official title: Open-label, Long-term Follow-up of Safety and Biochemical Disease Control of Infacort® in Neonates, Infants and Children With Congenital Adrenal Hyperplasia and Adrenal Insufficiency Previously Enrolled in the Infacort 003 Study
Key Details
Gender
All
Age Range
1 Month - 6 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2016-03-04
Completion Date
2018-08-10
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Infacort®
Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg).
Locations (1)
Charité-Universitätsmedizin Berlin, CVK
Berlin, Germany