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COMPLETED
NCT02733367
PHASE3

Extension Study for Patients Entered Into Study Infacort 003

Sponsor: Neurocrine UK Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

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