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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514127-42-00 | EU Trial (CTIS) Number |
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The main objective for this study is to evaluate the pharmacokinetics (PK) of crinecerfont in pediatric participants 0 to <2 years of age with congenital adrenal hyperplasia (CAH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crinecerfont | Experimental | Participants with CAH will receive crinecerfont during an initial 14-day treatment period, followed by an optional 36-month open-label extension (OLE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crinecerfont | Drug | Oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Crinecerfont | Days 7 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Month 37 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Berlin | 13353 | Germany | |||
| Neurocrine Clinical Site |
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| Düsseldorf |
| 40225 |
| Germany |
| Neurocrine Clinical Site | Heidelberg | 69120 | Germany |
| ID | Term |
|---|---|
| D000312 | Adrenal Hyperplasia, Congenital |
| ID | Term |
|---|---|
| D047808 | Adrenogenital Syndrome |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D043202 | Steroid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000723083 | crinecerfont |
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