A Phase 3 interventional study of Chronocort in Congenital Adrenal Hyperplasia, sponsored by Immedica Pharma AB. Completed at 21 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Immedica Pharma AB · Phase 3, Interventional, and Treatment
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).
Participants in eligible countries completing one of the specified previous Chronocort studies (DIUR-006 and DIUR 014) can either continue Chronocort treatment (if the participant received Chronocort in the feeder study) or switch to Chronocort treatment (if the participant received standard glucocorticoid therapy in the feeder study) in this open-label extension study. All participants choosing to enter this extension study will have the study procedures fully explained and informed consent obtained, prior to, or at the last visit of the feeder study. Participants who agree to take part in this extension study will then undergo the final visit of the feeder study, with the assessments conducted at the final visit also providing the baseline data for this DIUR-015 extension study where relevant (note participants who are withdrawn from treatment due to titration issues in study DIUR-014 are eligible to enter at the discretion of the Investigator, as long as all DIUR-014 safety assessments and the end of study visit are completed). Once all the baseline assessments are completed, participants will be given sufficient Chronocort to use until the next visit (the study pharmacies will be supplied with Chronocort for dispensing to participants according to the Investigators' instructions).
Outcome measures in this study will be assessed versus either the 'initial study baseline' (measurements taken at the start of participation in an interventional Chronocort study, regardless of the treatment assignment in this feeder study) or the protocol-defined 'pre-Chronocort baseline' (measurements taken prior to the first dose of continuous Chronocort) or the 'DIUR-015 baseline' (measurements taken at the start of participation in DIUR-015 study).
107 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 29 are open to participants now.
This study's enrollment of 76 is above the median of 36 across 55 interventional studies indexed under Adrenal Hyperplasia, Congenital.
Browse Adrenal Hyperplasia, Congenital studies →Immedica Pharma AB is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Chronocort (hydrocortisone modified-release capsules) supplied as 5 mg and 10 mg per capsule for oral administration.
Drug: Chronocort
Hydrocortisone modified-release capsule 5 mg and 10 mg
Also known as: Hydrocortisone modified-release hard capsule
Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study.
Over-replacement normally presents with chronic effects such as weight gain, increased appetite, sleeping difficulties, increased acne and Cushingoid syndrome.
Time frame: Up to 32 months
Signs and symptoms of under-treatment [Safety and Tolerability] throughout the study.
Under-replacement normally presents with acute effects such as sudden weight loss, lack of appetite, nausea, vomiting, headache, blurred vision, fatigue, weakness, dizziness, light-headedness and syncope.
Time frame: Up to 32 months.
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of use of additional glucocorticoid treatment throughout the study.
Use of Immediate Release Hydrocortisone (IRHC) from the emergency packs for stress dosing or use of any additional glucocorticoid treatment.
Time frame: Up to 32 months
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of incidence of adrenal crises throughout the study.
Occurrence of adrenal crises throughout the study.
Time frame: Up to 32 months
To measure the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
The incidence, nature, severity, relatedness, duration, outcome, seriousness, and expectedness of treatment-emergent adverse events (TEAEs) throughout the study.
Time frame: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of hematology safety laboratory assessments [Safety and Tolerability].
Lab parameters will be summarized and compared throughout the study as follows: Platelet count, Red blood cell count (RBC), Haemoglobin, Haematocrit, RBC Indices: Mean corpuscular volume (MCV), Mean cell haemoglobin (MCH). Mean cell haemoglobin concentration (MCHC), Red cell distribution width (RDW). White blood cell (WBC) count with differential (absolute and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils.
Time frame: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments [Safety and Tolerability].
To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments \[Safety and Tolerability\]. Blood urea nitrogen (BUN), Creatinine, Chloride, Total magnesium, Potassium, Sodium, Calcium, Total carbon dioxide (CO2), Inorganic phosphorus, AST/serum glutamic-oxaloacetic transaminase (SGOT), ALT/serum glutamic-pyruvic transaminase (SGPT), Alkaline phosphatase, Albumin, Total and direct bilirubin, Total protein, Lactate dehydrogenase (LDH), Total creatine kinase (CK), Uric acid.
Time frame: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of vital signs assessments.
Blood pressure measurements throughout the study will be summarised and compared.
Time frame: Up to 32 months
To assess the impact of treatment on dose of steroid required - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose at each visit.
Time frame: Up to 32 months
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from pre-Chronocort baseline
Change in 17-OHP levels from pre Chronocort baseline at each visit.
Time frame: Up to 32 months
To assess the impact of treatment on Androstenedione (A4) levels - Change from pre-Chronocort baseline
Change in A4 levels from pre-Chronocort baseline at each visit.
Time frame: Up to 32 months
To assess the impact of treatment on menstrual regularity (recorded in a participant diary) as a marker of fertility - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline in menstrual regularity as recorded in a participant diary. With menstrual regularity defined as a cycle (menstrual bleeding) occurring every 21 to 35 days (only in pre-menopausal females without hysterectomy and not using hormonal contraceptives).
Time frame: Up to 32 months
To assess the impact of treatment on luteinising hormone (LH) levels in men as a marker of fertility - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline in luteinising hormone (LH) levels throughout the study.
Time frame: Up to 32 months
To assess the impact of treatment on testosterone by sex - Change from pre-Chronocort baseline
Change in testosterone levels from pre-Chronocort baseline through the study, summarized by gender.
Time frame: Up to 32 months
To assess the impact of treatment on waist circumference - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline to each visit in waist circumference.
Time frame: Up to 32 months
To assess the impact of treatment on body weight - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline to each visit in body weight.
Time frame: Up to 32 months
To assess the impact of treatment on the dose of steroid - Change from initial study baseline daily dose
Change from initial study baseline in daily steroid dose as the hydrocortisone equivalent dose.
Time frame: Up to 32 months
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from initial study baseline
Change in 17-OHP levels from initial study baseline throughout the study.
Time frame: Up to 32 months
To assess the impact of treatment on Androstenedione (A4) levels - Change from initial study baseline
Change in A4 levels from initial study baseline throughout the study.
Time frame: Up to 32 months
To assess the impact of treatment on menstrual regularity (recorded in a participant diary) as a marker of fertility - Change from initial study baseline
Change from initial study baseline in menstrual regularity as recorded in a participant diary. With menstrual regularity defined as a cycle (menstrual bleeding) occurring every 21 to 35 days (only in pre-menopausal females without hysterectomy and not using hormonal contraceptives).
Time frame: Up to 32 months
To assess the impact of treatment on luteinising hormone (LH) levels in men as a marker of fertility - Change from initial study baseline
Change from initial study baseline on luteinising hormone (LH) levels throughout the study.
Time frame: Up to 32 months
To assess the impact of treatment on testosterone by sex - Change from initial study baseline
Change in testosterone from initial study baseline throughout the study, summarized by gender.
Time frame: Up to 32 months
To assess the impact of treatment on waist circumference - Change from initial study baseline
Change from initial study baseline throughout the study in waist circumference.
Time frame: Up to 32 months
To assess the impact of treatment on body weight - Change from initial study baseline
Change from initial study baseline throughout the study in body weight.
Time frame: Up to 32 months
To measure the change from pre-Chronocort baseline in Quality of Life (QoL) using the EuroQol 5-level Standardized Health Questionnaire (EQ 5D-5L™).
QoL will be summarized and compared throughout the study. The scale measures on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Where the minimum score is 0 and maximum score is 100, a high score indicates a more favorable outcome.
Time frame: Up to 32 months
To measure the change from initial study baseline in Quality of Life (QoL) using the EuroQol 5-level Standardized Health Questionnaire (EQ 5D-5L™).
QoL will be summarized and compared throughout the study. The scale measures on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Where the minimum score is 0 and maximum score is 100, a high score indicates a more favorable outcome.
Time frame: Up to 32 months
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Adrenal Hyperplasia, Congenital→
Immedica Pharma AB