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Abiraterone Acetate for Congenital Adrenal Hyperplasia
Study Summary
This trial is testing a new drug, abiraterone acetate, to see if it can be used to help treat children with a 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.Side effects data
From 2021 Phase 3 trial • 32 Patients • NCT01517802Trial Design
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- I have been taking fludrocortisone and at least 10 mg/m2/day of hydrocortisone for over a month.I have significant anemia or low iron levels in my blood.I don't have any health issues that could affect my growth or interfere with the study.I haven't taken systemic steroids for asthma or other conditions in the last 3 months.I am not on puberty or sex hormone altering drugs, but can start some if needed during the study.I am not taking growth hormone now and won't during the study.I am not allergic to abiraterone acetate or its ingredients.I have or had cataracts.I am not taking medications that could harm my liver or affect how other drugs work.I have or had hepatitis.My kidney tests show higher than normal levels.I have a confirmed diagnosis of classic 21-hydroxylase deficiency.My liver functions are normal, and I don't have ascites or encephalopathy.I have a condition that affects how my body absorbs nutrients.My child is between 2-8 years old for girls, or 2-9 for boys, and meets the weight and skeletal age requirements.Both my parents (or guardians) have signed the consent form, and I have given my assent if I'm 10 or older.You show signs of entering puberty, like breast development in girls or increased testicular size in boys, or higher levels of a hormone called luteinizing hormone. If you only have pubic or armpit hair, you can still participate.You have a significant abnormality in your heart's electrical activity as shown in a 12-lead electrocardiogram (ECG).My liver function has worsened during the study.I currently have active cancer.I do not have any serious illnesses or infections that are not under control.My androstenedione levels are high even after taking hydrocortisone.
- Group 1: Abiraterone acetate 4 mg/kg/d
- Group 2: Abiraterone acetate 1 mg/kg/d
- Group 3: Abiraterone acetate 2 mg/kg/d
- 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
Could I be a valid candidate for this research endeavor?
"Those who wish to be accepted into this research must have been diagnosed with adrenal hyperplasia, congenital and should lie between the ages of 2 and 9. A total of 36 participants are expected to join the study."
Does this research encompass seniors over the age of seventy?
"This medical research study is only open to minors aged between 2 and 9 years old. There are 32 trial sites for younger patients and 200 for elderly individuals over 65."
How many participants are eligible for enrollment in this scientific experiment?
"At present, this clinical trial is not actively enrolling; it was first published on 8/1/2017 and modified for the last time on 2/22/2022. For those seeking alternative studies, 137 trials are recruiting patients with adrenal hyperplasia congenital and 98 trials require Abiraterone acetate participants."
Has Abiraterone acetate been granted sanction by the FDA?
"Abiraterone acetate has only been tested in a limited capacity and therefore received a score of 1 on our safety scale due to it being an early-stage trial."
Are there any opportunities to participate in this research initiative currently?
"At the present time, this clinical trial is not enrolling any new participants. Initially posted on August 1st 2017 and last updated February 22nd 2022, individuals in search of other studies may have luck with 137 trials actively recruiting for adrenal hyperplasia congenital or 98 studies searching for Abiraterone acetate subjects."
Is Abiraterone acetate being tested in any additional experiments?
"Abiraterone acetate was first researched in 2005 at Rosemere Cancer Centre of Royal Preston Hospital. Over the course of 100 trials, 98 are still active with some based out of Dallas, Texas."
How prevalent is this clinical trial in the US health care system?
"This clinical trial is offering enrolment across seven sites, including Children's Medical Center in Dallas, Children's Hospital of Los Angeles in LA and University of Michigan Ann Arbor. Additionally there are four other recruiting locations."
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