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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal Hyperplasia

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.

Detailed Summary:

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 Any subjects not meeting the inclusion/exclusion criteria following these blood tests will be withdrawn from this study.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 visi
Sponsor: Diurnal Limited

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)

Original Secondary Outcome: Same as current

Information By: Diurnal Limited

Dates:
Date Received: August 22, 2016
Date Started: August 2016
Date Completion: February 2018
Last Updated: February 20, 2017
Last Verified: February 2017