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Protocol Details

A Phase 3 Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000740-CH

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

Yes

Population Exclusion(s)

Pregnant Women;
Children

Keywords

Congenital Adrenal Hyperplasia;
CAH;
Chronocort;
Adrenal Insufficiency;
Modified Release Hydrocortisone

Recruitment Keyword(s)

None

Condition(s)

Congenital Adrenal Hyperplasia

Investigational Drug(s)

Chronocort

Investigational Device(s)

None

Intervention(s)

Drug: Chronocort

Supporting Site

National Institute of Child Health and Human Development

Background:

Cortisol is a steroid hormone produced by the adrenal gland. If the adrenal gland does not produce enough cortisol, it can be life threatening. People with congenital adrenal hyperplasia (CAH) or other adrenal diseases must take drugs that replace the cortisol in their bodies. These drugs can cause side effects and complications. Better treatments are needed.

Objective:

To test a drug (Chronocort) in people with CAH.

Eligibility:

People aged 16 years and older with CAH who have completed studies DIUR-006 or DIUR-014.

Design:

Participants will make 3 or 4 visits to the clinic during their first year.

At each visit, after they pass screening for the study, participants will

Have a physical exam, with blood and urine tests

Answer questions about symptoms of adrenal insufficiency or overtreatment

Give details of their present and past treatments for CAH

Provide a list of other medications they take

Complete questionnaires about how CAH affects their life

Receive a supply of Chronocort

Chronocort is a capsule taken by mouth with water. Participants will take Chronocort at home twice a day, every day. Women will record details about their menstrual cycles.

After the first year, participants will come to the clinic once per year. They will receive welfare checks by telephone every 6 months. Researchers may also stay in touch by video calls, secure emails, and other means.

The study is expected to run through October 2025.

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Eligibility

INCLUSION CRITERIA:

Participants are eligible to be included in the study only if all of the following criteria apply (note: if a participant fails to meet an inclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):

-Participants with CAH who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014 .

-Participants who are capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

EXCLUSION CRITERIA:

Participants are excluded from the study if any of the following criteria apply (note: if a participant meets an exclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):

Medical Conditions

-Participants with clinical or biochemical evidence of hepatic or renal disease e.g., creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).

-Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).

-Participants with a history of bilateral adrenalectomy.

-Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.

Prior/Concomitant Therapy

-Participants with a co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids (examples at http://medicine.iupui.edu/clinpharm/ddis/clinicaltable/).

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

-Participants anticipating regular prophylactic use of additional steroids e.g., for strenuous exercise.

Prior/Concurrent Clinical Study Experience

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

Other Exclusions

-Females who are pregnant or lactating.

-Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.

-Participants who routinely work night shifts and so do not sleep during the usual night-time hours.

-Participants with a body weight of 50 kg or less. (Note: this exclusion criterion is only applicable for French sites).


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Citations:

Not Provided

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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:

NCT05299554

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