Diurnal Study

IRB
CHLA-22-00150
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia

This study is a randomized, double-blind, active-controlled, titrated, parallel arm, multicenter study. It will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily IRHC (Cortef®) over a randomized treatment period of up to 52 weeks in participants aged 16 years and over with known classic CAH due to 21-hydroxylase deficiency. The primary efficacy assessment of biochemical responder rate and the key secondary assessments of dose responder rate and mean total daily dose will be assessed after 52 weeks of randomized treatment.

Study Details
Keywords
Chronocort Hydrocortisone, replacement therapy, CAH, Congenital Adrenal Hyperplasia, 21-hydroxylase deficiency
Study Type
Randomized
Eligibility
16 years of age and older
Does this study also recruit healthy volunteers?
No
Enrollment Status
Open
Coordinator Contact
Norma Martinez
Contact Email
CAH@chla.usc.edu