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Corticosteroid
Chronocort vs Standard Therapy for Congenital Adrenal Hyperplasia (CONnECT Trial)
Phase 3
Waitlist Available
Led By D Merke
Research Sponsored by Diurnal Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female participants must be aged 16 years or older at the time of signing the informed consent/assent.
In participants aged <18 years, height velocity must be less than 2 cm/year in the last year and puberty must be completed (Tanner stage V).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks (assessed at baseline, 4, 10, 16 and 28 weeks)
Awards & highlights
CONnECT Trial Summary
This trial is testing a new treatment for Congenital Adrenal Hyperplasia, which is a disorder that affects the adrenal glands. The new treatment is being compared to the standard treatment to see if it is more effective.
Who is the study for?
This trial is for individuals over 16 with classic Congenital Adrenal Hyperplasia (CAH) treated with certain steroids for at least 3 months. They must not be pregnant, breastfeeding, or planning to become pregnant and agree to use contraception. Exclusions include previous Chronocort exposure, weight under 45 kg, night shift workers, certain medical conditions including uncontrolled diabetes, and those on other steroid treatments.Check my eligibility
What is being tested?
The study compares Chronocort®, a new therapy for CAH, against the standard immediate-release hydrocortisone (Cortef). It's a phase III trial where participants are randomly assigned to either treatment without knowing which one they receive (double-blind) to evaluate effectiveness and safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, both Chronocort® and Cortef can cause symptoms related to hormone imbalance such as fatigue, mood changes or skin issues. Side effects may also include signs of too much or too little steroid effect like swelling or weight gain.
CONnECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
If you are under 18, you must have grown less than 2 centimeters in the last year and have finished going through puberty.
Select...
If you take fludrocortisone, you must have been taking the same amount for at least 3 months before joining the study, and your renin levels must be stable.
CONnECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks (assessed at baseline, 4, 10, 16 and 28 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks (assessed at baseline, 4, 10, 16 and 28 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To compare Chronocort to IRHC in terms of biochemical responder rate after 28 weeks of randomized treatment - 17-OHP concentration
To compare Chronocort to IRHC in terms of biochemical responder rate after 28 weeks of randomized treatment - A4 concentration
To compare Chronocort to IRHC in terms of biochemical responder rate after 28 weeks of randomized treatment - Total daily dose of Hydrocortisone
Secondary outcome measures
To assess compliance over the study period.
To compare Chronocort to IRHC in terms of biochemical control at 10, 16, and 28 weeks after randomization.
To compare Chronocort to IRHC in terms of biochemical responders at 4, 10, 16, and 28 weeks after randomization.
+25 moreOther outcome measures
To assess dose changes over the study period - Change in mg
To assess dose changes over the study period - Incidence
To assess preference for treatment.
+28 moreSide effects data
From 2009 Phase 1 & 2 trial • 20 Patients • NCT0051981821%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cortef
Chronocort
CONnECT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ChronocortExperimental Treatment1 Intervention
Hydrocortisone modified-release capsule - Chronocort®. 25 subjects will be randomised to this group using an interactive response technology (IRT).
Group II: CortefActive Control1 Intervention
Immediate-release hydrocortisone capsule (IRHC) - Cortef. 25 subjects will be randomised to this group using an interactive response technology (IRT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chronocort
2021
Completed Phase 3
~140
Find a Location
Who is running the clinical trial?
Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
666 Total Patients Enrolled
D MerkePrincipal InvestigatorNational Institutes of Health Clinical Center, Bethesda, Maryland, US
1 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking steroids every day for reasons other than a specific condition called CAH.You have been diagnosed with a specific hormone deficiency called classic CAH since childhood and are currently taking certain medications for it.You weigh 45 kilograms or less.You work at night and don't sleep during regular nighttime hours.You have had a type of cancer, except for a certain type of skin cancer, that was treated more than 26 weeks ago.You have ongoing symptoms of adrenal insufficiency or you can't handle the treatment after the 4-week trial period.You have type 1 diabetes, uncontrolled diabetes, or a high HbA1c level.You are already part of a study that requires checking your hormone levels during the study period.You are taking less than 10 mg of hydrocortisone or a similar medication at the time of screening.You plan to regularly take extra steroids, like for intense exercise.You have a condition that makes it hard for your body to process sugars found in milk and other foods.If you are under 18, you must have grown less than 2 centimeters in the last year and have finished going through puberty.You have liver or kidney problems, as shown by certain blood tests being higher than normal.You have had surgery to remove both adrenal glands.You have a medical condition that requires you to take a medication every day, or consume something that affects how your body processes glucocorticoids.If you take fludrocortisone, you must have been taking the same amount for at least 3 months before joining the study, and your renin levels must be stable.
Research Study Groups:
This trial has the following groups:- Group 1: Chronocort
- Group 2: Cortef
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study widely available in many different clinics within the city?
"Right now, there are 7 sites where this clinical trial is enrolling patients. If you're considering participating in this study, know that locations include Bethesda, Orange, and Iowa City; with 7 other sites also hosting research. To cut down on travel time and costs, choose the location nearest to you."
Answered by AI
When will Chronocort be available to patients in the United States?
"There is some evidence supporting the efficacy of Chronocort, as this drug is in Phase 3 trials. Additionally, multiple rounds of data have shown that Chronocort is safe, so it receives a score of 3."
Answered by AI
Does literature exist on other Chronocort-based research?
"The first clinical trial for Chronocort was at the National Institutes of Health Clinical Center in 1995. To date, there have been a total of 174 completed studies with 63 ongoing trials. Many of these are based out of Bethesda, Maryland."
Answered by AI
What afflictions does Chronocort help alleviate?
"Chronocort is a medication that is commonly used to help those suffering from ulcerative colitis, but it can also be employed as part of the treatment plan for other illnesses such as malignant neoplasms and crohn disease."
Answered by AI
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