CALIBRATE: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

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Description

Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Details
Age

Child to Adult

Eligibility

Participant must be at least 16 years of age Participants must have a documented pathogenic or likely pathogenic activating variant, or variant of uncertain significance, of the CASR gene associated with biochemical findings of hypoparathyroidism either present at Screening or a documented history of both: a... cCa < 8.6 mg/dL (2.2 mmol/L) in participants 16 to < 18 years, or < 8.5 mg/dL (2.1 mmol/L) in participants &#8805; 18 years b. iPTH < 40 pg/mL (4.2 pmol/L)

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Nina Ma

Nina Ma

Study ID

Protocol Number: 23-1163

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