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Corticosteroid
Chronocort for Congenital Adrenal Hyperplasia
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 32 months
Awards & highlights
Study Summary
This trial will study the long-term safety of a drug for Congenital Adrenal Hyperplasia.
Who is the study for?
This trial is for individuals over 16 with Congenital Adrenal Hyperplasia (CAH) who've completed previous Chronocort studies. They must be able to consent and not have conditions that interfere with the study or glucocorticoid metabolism, no recent participation in other drug trials, not pregnant/lactating, and without severe liver/renal disease.Check my eligibility
What is being tested?
The trial is testing the long-term safety of a medication called Chronocort for treating CAH. It's an open-label extension study across multiple countries where participants will continue using Chronocort to assess its ongoing safety profile.See study design
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include potential impacts on organ function like liver or kidneys due to long-term medication use. Participants' health will be closely monitored for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 32 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study.
Signs and symptoms of under-treatment [Safety and Tolerability] throughout the study.
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of incidence of adrenal crises throughout the study.
+5 moreSecondary outcome measures
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from pre-Chronocort baseline
To assess the impact of treatment on Androstenedione (A4) levels - Change from pre-Chronocort baseline
To assess the impact of treatment on body weight - Change from pre-Chronocort baseline
+5 moreOther outcome measures
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from initial study baseline
To assess the impact of treatment on Androstenedione (A4) levels - Change from initial study baseline
To assess the impact of treatment on body weight - Change from initial study baseline
+7 moreSide effects data
From 2009 Phase 1 & 2 trial • 20 Patients • NCT0051981821%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cortef
Chronocort
Trial Design
1Treatment groups
Experimental Treatment
Group I: Chronocort (hydrocortisone modified-release capsule)Experimental Treatment1 Intervention
Chronocort (hydrocortisone modified-release capsules) supplied as 5 mg and 10 mg per capsule for oral administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved
Find a Location
Who is running the clinical trial?
Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
640 Total Patients Enrolled
D MerkePrincipal InvestigatorNational Instiututes of Health Clinical Centre, Bethesda, Maryland, United States, 20892-1932
1 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My body weight is 50 kg or less.I have had both of my adrenal glands removed.My kidney or liver tests show they are not working well.I use steroids daily for reasons other than adrenal gland disorders.I am not pregnant or breastfeeding.I can sign and agree to follow the study's rules.I had cancer other than basal cell carcinoma, treated successfully over 6 months ago.I take daily medication that affects how my body uses steroids.I plan to use steroids regularly for activities like intense workouts.
Research Study Groups:
This trial has the following groups:- Group 1: Chronocort (hydrocortisone modified-release capsule)
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are there any available openings for subjects in this trial?
"No, this particular clinical trial is not seeking new candidates at the moment. Although, it is worth noting that there are 147 other trials with open enrollment. This trial was initially posted on April 1st, 2022 and received its last update on October 14th, 2022."
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