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Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company
Summary
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
Official title: 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)
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2023-01-06
Completion Date
2029-08
Last Updated
2025-10-31
Healthy Volunteers
No
Conditions
Interventions
Encaleret
Administered as film-coated tablet for oral use
Standard of Care
Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Locations (25)
UCSF Benioff Children's Hospital, Oakland
Oakland, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
NIH
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Columbia University Irving Medical Center
New York, New York, United States
Physicians East
Greenville, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Bone Research & Education Centre
Oakville, Ontario, Canada
Vseobecna fakultni nemocnice v Praze
New Town, Czechia
Aarhus University Hospital
Aarhus, Denmark
CHU Bicetre
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France
Hôpital Edouard Herriot - HCL
Lyon, France
IRCCS Ospedale San Raffaele
Milan, Italy
University Hospital of Pisa
Pisa, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
The University of Tokyo Hospital
Tokyo, Japan
Eramus MC
Rotterdam, Netherlands
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom