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Protocol Details

A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort (Registered) in the Treatment of Congenital Adrenal Hyperplasia

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-CH-0164

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Adrenal Insufficiency;
Glucocorticoids;
Androgens;
CAH;
Chronocort

Recruitment Keyword(s)

None

Condition(s)

Congenital Adrenal Hyperplasia (CAH)

Investigational Drug(s)

Chronocort (registered)

Investigational Device(s)

None

Intervention(s)

Drug: Chronocort

Supporting Site

National Institute of Child Health and Human Development

Background:

People with congenital adrenal hyperplasia (CAH) do not make enough of two important adrenal hormones, but they make too much androgen. CAH is currently treated with medicines called glucocorticoids that are like cortisol. But natural cortisol is released in the body in different amounts throughout the day, with levels high in the morning and low at night. Researchers want to test a medicine, called Chronocort(R), a new preparation of the glucocorticoid named hydrocortisone which is designed to be released into the bloodstream more like natural cortisol.

Objective:

To determine the safety and effectiveness of Chronocort(R) over a maximum of 40 months.

Eligibility:

People with CAH who have successfully completed clinical trials studying Chronocort(R).

Design:

Participants will be screened based on their diagnosis and current treatment.

Participants will have up to 11 visits over 40 months. Visits will be either as an inpatient or an outpatient at NIH.

During study visits, participants will have a medical history and physical exam. They may have blood and urine tests. They may need to fast before visits.

Participants will get a supply of the study drug at each visit. Their dose may change during the study.

Participants will take study drug capsules twice a day.

Before each visit, participants will record the time and dose of the last study drug dose they took.

Participants will have a DEXA scan. This is a body composition scan.

Participants will answer questions about their quality of life.

Participants will be given sick day rules. These will tell them what to do if they have an illness.

Participants will be contacted by phone by the research team during and after the study.

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Eligibility

INCLUSION CRITERIA:

1. Subjects with congenital adrenal hyperplasia (CAH) who have successfully completed the DIUR-003 or DIUR-005 clinical trials with the current formulation of Chronocort (Registered Trademark)

2. Provision of signed written informed consent.

EXCLUSION CRITERIA:

1. Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) that interferes with the metabolism of glucocorticoids.

2. Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (ALT or AST >2 times the upper limit of normal [ULN]).

3. Females who are pregnant or lactating.

4. Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH.

5. History of malignancy (other than basal cell carcinoma successfully treated >6 months prior to entry into the study).

6. Subjects with a history of bilateral adrenalectomy.

7. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study, except for another clinical trial with the current formulation of Chronocort (Registered Trademark).

8. Subjects unable to comply with the requirements of the protocol.

9. Subjects who routinely work night shifts and so do not sleep do not sleep during the usual nighttime hours.


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Citations:

Mallappa A, Sinaii N, Kumar P, Whitaker MJ, Daley LA, Digweed D, Eckland DJ, Van Ryzin C, Nieman LK, Arlt W, Ross RJ, Merke DP. A phase 2 study of Chronocort, a modified-release formulation of hydrocortisone, in the treatment of adults with classic congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2015 Mar;100(3):1137-45. doi: 10.1210/jc.2014-3809. Epub 2014 Dec 11.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Deborah P. Merke, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 3-2740
10 CENTER DR
BETHESDA MD 20892
(301) 496-0718
dmerke@nih.gov

Elizabeth G. Joyal, C.R.N.P.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 3-2740
10 CENTER DR
BETHESDA MD 20892
(301) 496-8542
ejoyal@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03062280

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