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Tildacerfont for Congenital Adrenal Hyperplasia
Study Summary
This trial looks at whether the drug Tildacerfont is safe for children with Congenital Adrenal Hyperplasia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have any unstable or serious long-term health conditions.I have been on a stable dose of glucocorticoid replacement for at least 1 month.I have had surgery to remove both adrenal glands or have a condition affecting my pituitary gland.I am between 2 and 17 years old.I have CAH and need ongoing hormone therapy since my diagnosis.My adrenal hyperplasia is not caused by 21-hydroxylase deficiency.I am not pregnant or nursing.I have a history of bleeding disorders.
- Group 1: Cohort 7: Treatment with Tildacerfont
- Group 2: Cohort 5: Treatment with Tildacerfont
- Group 3: Cohort 9: Treatment with Tildacerfont
- Group 4: Cohort 4: Treatment with Tildacerfont
- Group 5: Cohort 8: Treatment with Tildacerfont
- Group 6: Cohort 6: Treatment with Tildacerfont
- Group 7: Cohort 1: Age 11-17 Treatment with Tildacerfont
- Group 8: Cohort 2: Age 11-17 Treatment with Tildacerfont
- Group 9: Cohort 3: Age 2-10 Treatment with Tildacerfont
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there an age limit for those wishing to participate in the research project?
"This trial is open to children aged between 6 and 17, with a total of 28 different clinical trials available for minors. Additionally, there are 105 distinct medical studies that cater towards elderly individuals above the age of 65."
Has Tildacerfont received regulatory approval from the Food and Drug Administration?
"This new treatment, tildacerfont, has not been tested for efficacy yet but there is sufficient clinical data to suggest it's safe. Therefore the safety rating of 2 was assigned by our team at Power."
Is there still an opportunity for individuals to enter this clinical trial?
"Affirmative. Clinicaltrials.gov implies that this clinical trial, initiated on December 10th 2021, is presently searching for participants. Around 20 patients are needed from four separate medical centres."
What sort of patient is most apt to join this clinical research?
"To be considered for the trial, participants must have a diagnosis of adrenocortical hyperfunction and fall within the age range of 6 to 17. The total number of enrollees is limited to 20 individuals."
How many North American sites are currently running this research project?
"Four medical institutions are currently taking part in this trial: University of Virginia (Charlottesville), University of Utah (Salt Lake City), Indiana University Hospital (Indianapolis) and four other sites."
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