drugset / Trial / NCT03548246
Androgen Reduction in Congenital Adrenal Hyperplasia
Phase 2
Withdrawn
University of Texas Southwestern Medical Center
Children's Hospital Los Angeles · collabFeinstein Institute for Medical Research · collabNational Institutes of Health Clinical Center (CC) · collabUniversity of Michigan · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to have elevated circulating levels of androgens, which can accelerate skeletal maturation and adversely impact adult height. Additionally, these children require supraphysiologic doses of hydrocortisone to suppress secretion of adrenal androgen precursors, and this treatment can retard linear growth. This study seeks to use oral abiraterone acetate (Zytiga)as an adjunct to approved CAH therapy (oral hydrocortisone and fludrocortisone) for pre-pubescent children with classic 21-hydroxylase deficiency in order to reduce daily requirement of hydrocortisone.
Timeline
- Start
- 2023-01
- Primary completion
- 2026-01
- Completion
- 2026-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | — | Oral |
| Background | Fludrocortisone | Other / unclassified | — | — |
| Background | Hydrocortisone | Other / unclassified | 7 mg/m2 | — |
| Background | Hydrocortisone | Other / unclassified | 9 mg/m2 | — |