drugset / Trial / NCT02733367
Extension Study for Patients Entered Into Study Infacort 003
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |