Adrenal Insufficiency Clinical Trial
Official title:
A Phase 2 Pilot Study to Characterize and Examine the Pharmacokinetics and Disease Bio-marker Response of Chronocort® in Adults With Congenital Adrenal Hyperplasia
The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.
This study is a Phase 2 pilot study to characterize and examine the pharmacokinetics and efficacy profile of Chronocort® in adults with congenital adrenal hyperplasia (CAH). It is designed as a two-part, single cohort, open label, multiple dose Phase 2 pilot study to: (Part A) characterize and examine the pharmacokinetics (PK) and disease bio-marker behavior following short-term dosing with Chronocort®; and to (Part B) examine the disease control after six months dose titration with Chronocort® in adults with CAH. ;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT03282487 -
Optimising Steroid Replacement in Patients With Adrenal Insufficiency
|
Phase 4 | |
| Not yet recruiting |
NCT05716607 -
Treatment Study in Patients Treated With Both Insulin & Hydrocortisone
|
N/A | |
| Not yet recruiting |
NCT06435481 -
Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics
|
Phase 4 | |
| Recruiting |
NCT03399383 -
Adherence in Chronic Adrenal Insufficiency
|
N/A | |
| Completed |
NCT01428336 -
Value of 25 mcg Cortrosyn Stimulation Test
|
N/A | |
| Completed |
NCT00851942 -
Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test
|
Phase 4 | |
| Withdrawn |
NCT00368381 -
Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis
|
Phase 4 | |
| Active, not recruiting |
NCT04519580 -
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
|
||
| Recruiting |
NCT06008184 -
Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
|
||
| Completed |
NCT03013166 -
THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone
|
||
| Enrolling by invitation |
NCT02282150 -
Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism
|
Phase 4 | |
| Completed |
NCT02934399 -
Dynamic Hormone Diagnostics in Endocrine Disease
|
||
| Completed |
NCT03000231 -
Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency
|
||
| Completed |
NCT01960530 -
An Investigational Study of Hydrocortisone
|
Phase 1 | |
| Completed |
NCT00552487 -
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
|
N/A | |
| Completed |
NCT00575341 -
Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency
|
Phase 3 | |
| Completed |
NCT00471900 -
Six Months DHEA Treatment in Female Adrenal Failure
|
N/A | |
| Completed |
NCT03294876 -
Rheumatoid Arthritis Adrenal Recovery Study
|
||
| Completed |
NCT03709381 -
Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study
|
Early Phase 1 | |
| Recruiting |
NCT05639127 -
The Treatment of Adrenal Crisis With Inhaled Prednisolone
|
Early Phase 1 |