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Corticosteroid

Abiraterone acetate for Congenital Adrenal Hyperplasia (ARCH Trial)

Phase 2
Waitlist Available
Led By Perrin C White, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks
Awards & highlights

ARCH Trial Summary

This trial is testing whether using the drug Zytiga in addition to the usual treatments for CAH (hydrocortisone and fludrocortisone) can reduce the amount of hydrocortisone these children need.

Eligible Conditions
  • Congenital Adrenal Hyperplasia

ARCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone age advancement
Secondary outcome measures
Body mass index Z-score
Hydrocortisone dose required to normalize androstenedione levels
Number of adverse events
+2 more

Side effects data

From 2021 Phase 3 trial • 32 Patients • NCT01517802
10%
Pulmonary Embolism
6%
Diarrhoea
6%
Fall
6%
Skin Laceration
3%
Urinary Retention
3%
Acute Kidney Injury
3%
Cardiac Failure Congestive
3%
Musculoskeletal Pain
3%
Oesophagitis
3%
Myocardial Infarction
3%
Nausea
3%
Vomiting
3%
Aortic Thrombosis
3%
Hypertension
3%
Dyspnoea
3%
Fatigue
3%
Weight Decreased
3%
Lower Respiratory Tract Infection
3%
Urinary Tract Infection
3%
Dehydration
3%
Cerebrovascular Accident
3%
Encephalopathy
3%
Spinal Cord Compression
3%
Syncope
3%
Cardiac Failure
3%
Upper Limb Fracture
3%
Aortic Valve Replacement
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abiraterone Acetate + Prednisone/Prednisolone

ARCH Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abiraterone acetateExperimental Treatment3 Interventions
Abiraterone acetate administered daily in dose determined in Phase 1, plus usual maintenance treatment with hydrocortisone and fludrocortisone..
Group II: PlaceboPlacebo Group3 Interventions
Daily placebo, plus usual maintenance treatment with hydrocortisone and fludrocortisone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludrocortisone
2016
Completed Phase 1
~380
Abiraterone acetate
2014
Completed Phase 3
~3440
Hydrocortisone
2005
Completed Phase 4
~1260

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)NIH
383 Previous Clinical Trials
881,198 Total Patients Enrolled
Feinstein Institute for Medical ResearchOTHER
21 Previous Clinical Trials
5,672 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,799 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I qualify to be a subject in this experiment?

"Eligible patients for this clinical trial must have adrenogenital syndrome and be aged between 2-9. Up to 54 total participants will be accepted into the study."

Answered by AI

What other scientific research has been done on Abiraterone acetate?

"Abiraterone acetate was first studied in 1995 at National Institutes of Health Clinical Center. As of now, 18542 studies have been completed with 166 more currently underway. The majority of these active trials are taking place in Los Angeles, California."

Answered by AI

Are there any current open slots for participants in this experiment?

"As of December 17th, 2021 this specific trial is no longer recruiting patients. It was first posted on January 1st, 2023. If you're looking for other trials, there are presently 145 studies actively enrolling participants with adrenogenital syndrome and 166 trials for Abiraterone acetate admitting patients."

Answered by AI

What is the total number of individuals taking part in this experiment?

"As of right now, this trial is not recruiting patients. The listing for this clinical study was first posted on January 1st 2023 and was last edited December 17th 2021. If you are interested in other studies, there are 145 trials actively enrolling participants with adrenogenital syndrome and 166 for Abiraterone acetate that still need patients."

Answered by AI

Does this research exclude senior citizens?

"As specified in the eligibility requirements, patients between 2 and 9 years old may enroll in this clinical trial."

Answered by AI

Are there different hospitals participating in this research project within the city limits?

"4 clinical sites are enrolling patients for this study, which include locations such as Children's Hospital of Los Angeles and University of Michigan. Other centres where you can participate in the trial are located in Dallas, amongst 3 other cities."

Answered by AI

Has Abiraterone acetate received official government sanctioning for patient use?

"Abiraterone acetate is still in Phase 2 of clinical trials, so there is only anecdotal evidence supporting its safety."

Answered by AI

For what purpose is Abiraterone acetate typically prescribed?

"Abiraterone acetate is commonly used to treat ulcerative colitis. Additionally, this medication can be helpful for patients with crohn disease, varicella-zoster virus acute retinal necrosis, and malignant neoplasms."

Answered by AI
~0 spots leftby Jan 2026