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A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH

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ClinicalTrials.gov Identifier: NCT03062280
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Diurnal Limited

Brief Summary:
Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will be offered the opportunity either to continue Chronocort® therapy or to switch from their current glucocorticoid therapy to Chronocort® in this open-label study.

Condition or disease Intervention/treatment Phase
Congenital Adrenal Hyperplasia Drug: Hydrocortisone Phase 3

Detailed Description:

All subjects will have a screening visit prior to the baseline assessment to allow DIUR-006 procedures to be fully explained and informed consent to be given by the subject. For subjects from DIUR-003 this screening visit will include safety blood tests. Any subjects not meeting the inclusion/exclusion criteria following these blood tests will be not be entered into the study.

All subjects will then return for the baseline visit. For subjects entering from study DIUR-003 the full set of baseline assessments will be completed, including 2 blood samples (one at 09:00 and one at 13:00 hours) for 17-OHP and A4. For subjects entering from DIUR-005, test results from their last visit in the feeder study (Visit 4) will be used for this baseline assessment, with the 09:00 and 13:00 hour results taken from the 24-hour hormone profiles conducted at the visit. Any subjects not meeting the inclusion/exclusion criteria following these blood tests will be withdrawn from this study.

Once the baseline assessments are completed, the subjects will be given sufficient Chronocort® to use until the next visit at Week 4. Subjects from study DIUR-005 who were previously on Chronocort® will continue on the same dose of Chronocort® that they were receiving at the end of the feeder study. Subjects from study DIUR-005 on standard therapy and subjects from study DIUR-003 will have their initial dose of Chronocort® determined using the hydrocortisone equivalent of baseline therapy.

All subjects will return to the study centre at 4, 12 and 24 weeks after starting study DIUR-006 for additional blood tests and dose titration, if necessary. Visits thereafter will take place at 6-monthly intervals. If there is a change of dose, an interim visit will be needed inbetween the 6-monthly visits.

All subjects will receive telephone calls at 3 monthly intervals, and unscheduled visits will be arranged if necessary. Subjects will also be provided with Chronocort® supplies from the study pharmacy at 3-monthly intervals.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal Hyperplasia
Actual Study Start Date : August 18, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Experimental: Chronocort®
Chronocort® modified release hydrocortisone
Drug: Hydrocortisone
Modified release hydrocortisone




Primary Outcome Measures :
  1. Safety and tolerability of Chronocort, as assessed by the incidence of treatment-emergent adverse events [ Time Frame: 2.5 years ]
    Safety and tolerability of Chronocort® over time, as assessed by the incidence of treatment-emergent adverse events.

  2. Safety and tolerability of Chronocort, as assessed by clinical observation. [ Time Frame: 2.5 years ]
    Safety and tolerability of Chronocort® over time, as assessed by clinical observation.

  3. Safety and tolerability of Chronocort, as assessed by laboratory measures. [ Time Frame: 2.5 years ]
    Safety and tolerability of Chronocort® over time, as assessed by laboratory measures.


Secondary Outcome Measures :
  1. Total daily dose of Chronocort® in mg/day of hydrocortisone [ Time Frame: 2.5 years ]
    Total daily dose of Chronocort® in mg/day of hydrocortisone during the study and the incidence of dose titrations

  2. Serum 17-OHP levels [ Time Frame: 2.5 years ]
    Serum 17-OHP levels when measured at two time points (at 09:00 and 13:00 hours at each study visit)

  3. Serum A4 levels [ Time Frame: 2.5 years ]
    Serum A4 levels, measured at two time points (at 09:00 and 13:00 hours at each study visit)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with CAH who have successfully completed a clinical trial with the current formulation of Chronocort®.
  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 over twice the ULN or elevated liver function tests (ALT or AST >2 times 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®.
  8. Subjects unable to comply with the requirements of the protocol.
  9. Subjects who routinely work night shifts and so do not sleep during the usual nighttime hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062280


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892-1932
Sponsors and Collaborators
Diurnal Limited
Investigators
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Principal Investigator: Debbie Merke, MD National Institutes of Health (NIH)

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Responsible Party: Diurnal Limited
ClinicalTrials.gov Identifier: NCT03062280     History of Changes
Other Study ID Numbers: DIUR-006
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Diurnal Limited:
Extension study

Additional relevant MeSH terms:
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Hyperplasia
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents