drugset / Trial / NCT02733367

Extension Study for Patients Entered Into Study Infacort 003

NCT02733367

Phase 3 Completed 18 enrolled Neurocrine UK Limited
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-03-04
Primary completion
2018-08-10
Completion
2018-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 0.5 mg
Subject Hydrocortisone Other / unclassified 1 mg
Subject Hydrocortisone Other / unclassified 2 mg
Subject Hydrocortisone Other / unclassified 5 mg