A Phase 1/2 interventional study of Chronocort and Cortef in Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency and Adrenogenital Syndrome, sponsored by Neurocrine UK Limited. Completed at 1 site in United States. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by Neurocrine UK Limited (formerly part of Neurocrine Biosciences) · Phase 1/2, Interventional, and Treatment
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Among 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital — 1 open to participants now, 1 under way, none of them phase 3. Hydrocortisone · Adrenal Hyperplasia, Congenital.
Among the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital, this one is the 10th largest by enrollment, is one of 2 that started in 2007, is one of 2 in phase 1/2, and was the 2nd registered.
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
Browse Adrenal Hyperplasia, Congenital studies →1 of the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital is open now, in 1 country. Recruiting first, the newest first:
Federico II University · Sites in Italy
Ages 18+
By country, each count listing its studies:
Hydrocortisone: first FDA approval 1951 (HYDROCORTONE), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 20 Adrenal Hyperplasia, Congenital studies recruiting now, 10 (50%) set no upper age limit and 9 (45%) stop at 75 or younger; 7 take children under 18; none take healthy volunteers.
This study: 16 Years to 60 Years · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 6 · Phase 4 2
First in 1995; this study’s year is marked. 2 started in 2007.
This study's enrollment of 20 is below the median of 37 across 50 interventional studies indexed under Adrenal Hyperplasia, Congenital.
Median enrollment 28 across the 17 interventional studies. Of the 13 that completed or were terminated, 8 (62%) have results posted.
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9 of 17 have an industry lead sponsor. The 9 most frequent:
This study is registered under Neurocrine UK Limited, one of the names counted as Neurocrine Biosciences. Under that name alone:
Neurocrine UK Limited is the lead sponsor of 18 studies on the registry; none are open to participants now.
16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences: 2 open now, 5 under way, 2 of them phase 3. Of 9 finished, 7 (78%) have results posted.
Among the 16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences, this one is the 9th largest by enrollment, is the only one that started in 2007, is the only one in phase 1/2, and was the 1st registered.
Neurocrine Biosciences’s Adrenal Hyperplasia, Congenital studies by the year they started, since 2007.
1 of the studies testing hydrocortisone in Adrenal Hyperplasia, Congenital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03760835Federico II UniversityCongenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | 2026-12-31 |
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Among the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Neurocrine Biosciences’s 16 in Adrenal Hyperplasia, Congenital:
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This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and prednisone) are currently used to treat CAH, but finding the best dose of these drugs that effectively lowers androgens without causing undesirable side effects, such as weight gain and slow growth rate in children, is often difficult to achieve.
Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this study. Children 16 years of age and older are eligible with confirmation by bone age that they are no longer growing.
Participants undergo the following tests and procedures during two inpatient visits one month apart at the NIH Clinical Center:
Between the two hospitalizations, patients are contacted by NIH weekly to check for possible side effects from Chronocort. Two weeks after the first visit, patients also will have blood drawn by their regular doctor or a local clinic. A few days before the second hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and well being.
About 30 days after discharge from the second hospitalization, patients are followed up with a telephone call to see how they are doing.
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a disease of the adrenal cortex characterized by cortisol deficiency with or without aldosterone deficiency, and androgen excess. The severe or classic form occurs in 1 in 15,000 births worldwide, while the mild non-classic form is a common cause of hyperandrogenism. The discovery of glucocorticoid therapy as a treatment for CAH occurred in the 1950's resulting in patients with classic CAH surviving to live a normal lifespan. However, existing treatment is suboptimal and many unresolved clinical problems exist. Standard hormone replacement often fails to normalize the growth and development of children with CAH, and adults may experience iatrogenic Cushing syndrome, hyperandrogenism, infertility or the development of the metabolic syndrome. Chronocort, a newly-developed formulation of hydrocortisone, results in a slow release of hydrocortisone that is designed to mimic the normal cortisol circadian rhythm. This new medical strategy, physiologic cortisol replacement, offers the prospect of an improved outcome of treatment. Chronocort has been safely given to healthy adult males in pharmacokinetic studies. This first ever study in patients with CAH is a pharmacokinetic/pharmacodynamic study comparing Chronocort to Cortef, the conventional immediate-release form of hydrocortisone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Satisfactory pre-trial screening
Provision of signed written and written assent from patients less than 18 years old, as applicable.
Good general health.
Females of must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using medically acceptable method of .
EXCLUSION CRITERIA:
Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of .
Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (Transaminases greater than 1.5 the ).
Females who are pregnant or lactating.
Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
Participation in another clinical trial of an or licensed drug or device within 3 months prior to inclusion in this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cortef 3 times daily(total dose 30 mg)for minimum of 7 days followed by Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration
Drug: Chronocort · Drug: Cortef
Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration
Also known as: Hydrocortisone modified release tablet treatment
Cortef 3 times daily(total dose 30 mg)for minimum of 7 days
Also known as: Hydrocortisone immediate release tablet
Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).
Time frame: Cortef after one week, Chronocort after one month
17 Hydroxyprogesterone at 08.00 Hours
Time frame: Cortef after one week compared with Chronocort after one month
| Milestone | Cortef Then Chronocort |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
| h*nmol/l | Cortef | Chronocort |
|---|---|---|
| Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose). | 5380 ± 414 | 3973 ± 166 |
| nmol/l | Cortef | Chronocort |
|---|---|---|
| 17 Hydroxyprogesterone at 08.00 Hours | 16.4 ± 27.9 | 86.9 ± 181.7 |
Collected over Adverse events for each subject were followed for 1 week in Cortef, 4 weeks on Chronocort and 4 weeks follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronocort | — | 0/14 (0%) | 4/14 (28.6%) |
| Cortef | — | 0/14 (0%) | 3/14 (21.4%) |
| Event | Chronocort | Cortef |
|---|---|---|
| HeadacheNervous system disorders | 4/14 | 3/14 |
| Age, Categorical(Participants) | Cortef Then Chronocort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Age, Continuous(years) | Cortef Then Chronocort |
|---|---|
| Mean | 26.8 ± 3.8 |
| Sex: Female, Male(Participants) | Cortef Then Chronocort |
|---|---|
| Female | 7 |
| Male | 7 |
| Region of Enrollment(participants) | Cortef Then Chronocort |
|---|---|
| United States | 14 |
The record gives a start of Aug 2007, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 5 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone
Adrenal Hyperplasia, Congenital →