Phase 3
N=18
Extension Study for Patients Entered Into Study Infacort 003
Adrenal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02733367 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Sep 2019
Primary outcome: Primary: Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) — 193; 9; 0; 42 adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Infacort® (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Neurocrine UK Limited
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) |
193; 9; 0; 42; 151 | — |
| SECONDARY Growth Velocity |
0.6343; 0.9214 | — |
| SECONDARY Cortisol Levels |
43.329; 22.022 | — |
| SECONDARY Number of Participants Exhibiting a Change in Tanner Development Stage |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
Subjects successfully completing study Infacort 003, whose inclusion criteria were:
- Male and female children less than 6 years of age.
- A diagnosis of adrenal insufficiency (AI) as confirmed by an inappropriately low cortisol usually with other supporting tests.
- Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without fludrocortisone).
- Adequately hydrated and nourished. In addition, the parents/carers must be able to understand and give written Informed Consent for this extension study.
Exclusion Criteria
- Clinically evident acute AI (adrenal crisis) (Note: the subject can be re-evaluated for eligibility once the episode is over)
- Inability of the child to take oral therapy
- Subjects with clinical signs of acute infection or fever on inclusion (Note: the subject can be re-evaluated for eligibility once the episode is over)
- Any surgical or medical condition that in the opinion of the Investigator may place the subject at higher risk from his/her participation in the study
- Parents/carers of subjects unwilling to consent to saving and propagation of pseudonymised medical data for study reasons
- Subjects who are in a dependent relationship with the Investigator or the Sponsor
Data sourced from ClinicalTrials.gov (NCT02733367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.