CONGENITAL ADRENAL HYPERPLASIA
Conditions
Brief summary
Primary Safety Endpoints: Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs) and any adverse events (AEs) leading to discontinuation Incidence of glucocorticoid (GC) deficiency/adrenal insufficiency and adrenal crisis Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH) Primary Efficacy Endpoint: Change from baseline in morning (before 11:00 AM) serum A4 over time
Detailed description
Secondary Efficacy Endpoints Change from baseline in morning (before 11:00 AM) serum 17-OHP over time Change from baseline in daily GC dose (hydrocortisone [HC] mg equivalents) over time
Interventions
None listed
Sponsors
Crinetics Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoints: Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs) and any adverse events (AEs) leading to discontinuation Incidence of glucocorticoid (GC) deficiency/adrenal insufficiency and adrenal crisis Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH) Primary Efficacy Endpoint: Change from baseline in morning (before 11:00 AM) serum A4 over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints Change from baseline in morning (before 11:00 AM) serum 17-OHP over time Change from baseline in daily GC dose (hydrocortisone [HC] mg equivalents) over time | — |
Countries
Germany, Italy
Outcome results
None listed