At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 18 enrolled
Drug / intervention
Infacort®drug
Likely dose
Infacort® 5.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Infacort® for Adrenal Insufficiency. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdrenal Insufficiency
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedApr 2016
Primary CompletionAug 2018
TodayJul 2026
First PostedApr 11, 2016
Enrollment StartMar 4, 2016
Primary CompletionAug 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.2 years ago
Interventions
Infacort®drug
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).