Extension Study for Patients Entered Into Study Infacort 003
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|ClinicalTrials.gov Identifier: NCT02733367|
Recruitment Status : Completed
First Posted : April 11, 2016
Results First Posted : September 13, 2019
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adrenal Insufficiency||Drug: Infacort®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 4, 2016|
|Actual Primary Completion Date :||August 10, 2018|
|Actual Study Completion Date :||August 10, 2018|
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).
- Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: 29 months ]The primary endpoint was the nature and occurrence of serious adverse events (SAEs) and adverse events (AEs) observed throughout the study. AEs were recorded from the time of the first intake of Infacort until the final visit.
- Growth Velocity [ Time Frame: 29 months ]Growth velocity standard deviation score (SDS). Body height/length (cm) was obtained at each visit by specially trained paediatric endocrine nurses or physicians using standard calibrated auxological methods.
- Cortisol Levels [ Time Frame: 29 months ]Cortisol levels measured from dried blood spots. The dried blood spots were analysed for multi-steroids, including cortisol (all subjects). Blood spot absolute laboratory values for the safety population are presented. A dried blood spot sample was collected at the initial and final visits, every month for the first 2 months of the study and thereafter every 6 months (unless required after 3 months).
- Number of Participants Exhibiting a Change in Tanner Development Stage [ Time Frame: 29 months ]The Tanner Development Stage was assessed as an additional analysis in this study. All assessments (breast, genitalia, and pubic hair) were Grade 1 (pre-pubertal) at baseline, with only 1 subject (in Cohort 2) showing a change during the study. Subject 018 showed progression to Grade 2 in the pubic hair category (sparse, pigmented hair mainly on labia).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733367
|Charité-Universitätsmedizin Berlin, CVK|
|Berlin, Germany, 13353|
|Principal Investigator:||Wiegand||Charite University, Berlin, Germany|