drugset / Trial / NCT01771328

Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia

NCT01771328

Phase 2 Unknown 20 enrolled Haukeland University Hospital
RandomizedCrossoverOpen-labelTreatment

Summary

The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method was recently applied to treat a patient through a critical phase of puberty. This is a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is to determine the effects of CSHI on metabolic parameters (androstenedione and 17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH), cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary objectives are to determine effects on clinical status, body weight, blood pressure and other metabolic parameters, as well as on subjective health status (AddiQoL, SF36).

Timeline

Start
2013-02
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cortisone acetate Other / unclassified 25 mg Oral
Comparator Hydrocortisone Other / unclassified 10 mg/m2 Subcutaneous