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
|Condition or disease||Intervention/treatment||Phase|
|Congenital Adrenal Hyperplasia||Drug: Hydrocortisone||Phase 3|
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 Any subjects not meeting the inclusion/exclusion criteria following these blood tests will be withdrawn from this study.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Chronocort® modified release hydrocortisone
Modified release hydrocortisone
- 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.
- 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.
- 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.
- 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
- 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)
- 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)
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
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892-1932|
|Principal Investigator:||Debbie Merke, MD||National Institutes of Health (NIH)|