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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2022 |
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Main ID: |
NCT03062280 |
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Date of registration:
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22/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH
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Scientific title:
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A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal Hyperplasia |
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Date of first enrolment:
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August 18, 2016 |
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Target sample size:
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92 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03062280 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Debbie Merke, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institutes of Health (NIH) |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Congenital Adrenal Hyperplasia
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Intervention(s)
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Drug: Hydrocortisone
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Primary Outcome(s)
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Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort® baseline in vital signs, weight, body mass index (BMI) and waist circumference.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort® baseline in safety laboratory assessments.
[Time Frame: 5.5 years (Assessed at visits: Screening [V0], Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Safety and tolerability of Chronocort, as assessed by the occurrence of adrenal crises.
[Time Frame: 5.5 years (Assessed at visits: Visit 2, Visit 3, Visit 4 then every 6 months and final visit)]
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Safety and tolerability of Chronocort over time, as assessed by signs and symptoms of adrenal insufficiency.
[Time Frame: 5.5 years (Assessed at visits: Visit 2, Visit 3, Visit 4 then every 6 months and final visit)]
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Safety and tolerability of Chronocort, as assessed by incidence of use of sick day rules.
[Time Frame: 5.5 years (Assessed at visits: Visit 2, Visit 3, Visit 4 then every 6 months and final visit)]
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Safety and tolerability of Chronocort, as assessed by the occurrence of adverse events (AEs).
[Time Frame: 5.5 years]
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Secondary Outcome(s)
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline at each visit in body composition.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline at each visit in incidence of dose titrations.
[Time Frame: 5.5 years (Assessed at visits: Visit 2, Visit 3, Visit 4 then every 6 months)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in Standarad Deviation Score (SDS) of 17-OHP.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline at each visit in total Testosterone
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline at each visit in Quality of Life
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in absolute values of A4.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by total daily dose of Chronocort in mg/day of hydrocortisone and by Body Surface Area (BSA).
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in SDS of A4.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline at each visit in hsCRP and PRA
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by serum 17-OHP levels.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by serum A4 levels
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in absolute values of 17-OHP.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 2, Visit 3, Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline at each visit in bone turnover markers
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort® baseline in fasting insulin, blood glucose levels, and HbA1c.
[Time Frame: 5.5 years (Assessed at visits: Baseline [V1], Visit 4 then every 6 months and Final visit)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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