Start Date
January 31, 2023
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Abiraterone acetate
Daily oral abiraterone acetate for 2 years. The dose will be specified based on pharmacodynamic data from Phase 1.
Placebo
Daily placebo for 2 years.
Hydrocortisone
Hydrocortisone will be administered at a starting dose of 7-9 mg/M2/d and adjusted as necessary based on 17-hydroxyprogesterone and ACTH levels.
Fludrocortisone
Fludrocortisone will be administered at the dose the subject was taking a study entry and adjusted as necessary to keep plasma renin in the high normal range.
National Institutes of Health, Bethesda
University of Michigan, Ann Arbor
Children's Medical Center, Dallas
Children's Hospital of Los Angeles, Los Angeles
Collaborators (1)
National Institutes of Health Clinical Center (CC)
NIH
University of Michigan
OTHER
Children's Hospital Los Angeles
OTHER
Feinstein Institute for Medical Research
OTHER
University of Texas Southwestern Medical Center
OTHER