Autosomal Dominant Hypocalcemia Types 1 And 2 (ADH1/2) Disease Monitoring Study (DMS)

Status: Active_not_recruiting
Location: See all (27) locations...
Study Type: Observational
SUMMARY

A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 90
Healthy Volunteers: f
View:

• Have a documented activating variant or variant of uncertain significance of the CASR gene causative of ADH1 or documented activating variant or variant of uncertain significance of the GNA11 gene causative of ADH2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment

⁃ Note: Acceptable documentation includes CASR or GNA11 genetic analysis report. If no prior documented CASR or GNA11 gene variant or variant of uncertain significance, potential participants can undergo CASR and GNA11 gene variant analysis at Screening.

• Be willing and able to provide informed consent or assent after the nature of the study and its details have been explained, and prior to any research-related procedures

• Be willing and able to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available

• Be willing and able to comply with the study visit schedule and study procedures

Locations
United States
California
University of California, San Francisco (UCSF) - Benioff Children's Hospital - Oakland
Oakland
Colorado
Children's Hospital Colorado
Aurora
Florida
Nemours Children's Clinic
Jacksonville
Indiana
Indiana University (IU) School of Medicine - University Hospital
Indianapolis
Massachusetts
Boston Children's Hospital
Boston
Minnesota
Mayo Clinic
Rochester
North Carolina
Physician's East Endocrinology
Greenville
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio State University Medical Center (OSUMC)
Columbus
Other Locations
Australia
Royal North Shore Hospital
Saint Leonards
Belgium
Universitaire Ziekenhuizen Leuven
Leuven
Canada
Bone Research and Education Centre
Oakville
Denmark
Aarhus University Hospital
Aarhus
Finland
Helsinki University Hospital (HUS) - The New Children's Hospital
Helsinki
France
HCL Hopital Femme Mere Enfant
Bron
Departement d'Endocrinologie et Diabetes pour Enfants - AP-HP Hopital Bicetre
Le Kremlin-bicêtre
CHU de Lille
Lille
HCL Hopital Edouard Herriot
Lyon
Germany
Endokrinologikum Gottingen
Göttingen
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan
IRCCS Ospedale San Raffaele
Milan
Policlinico Universitario Campus Bio-Medico
Rome
Japan
Osaka University Hospital
Osaka
The University of Tokyo Hospital
Tokyo
Netherlands
Erasmus MC
Rotterdam
Portugal
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
Lisbon
United Kingdom
Royal Manchester Children's Hospital
Manchester
Time Frame
Start Date: 2022-01-20
Completion Date: 2028-12
Participants
Target number of participants: 95
Treatments
ADH 1/2 DMS
Participants with ADH1 or ADH2. No investigational product will be administered to participants in this study. Participants will only receive standard of care (SoC) treatment as directed by the participants' treating physicians.
Related Therapeutic Areas
Sponsors
Leads: Calcilytix Therapeutics, Inc., a BridgeBio company

This content was sourced from clinicaltrials.gov

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