Status:
ACTIVE_NOT_RECRUITING
ADH1 and ADH2 Disease Monitoring Study (DMS)
Lead Sponsor:
Calcilytix Therapeutics, Inc., a BridgeBio company
Conditions:
Autosomal Dominant Hypocalcemia
Eligibility:
All Genders
Up to 90 years
Brief 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...
Detailed Description
The ADH1 and ADH2 DMS is designed to better understand the disease burden of ADH1 and ADH2, how participants with ADH1 or ADH2 are managed with standard of care practices in a real-world setting, and ...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Have serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures
- Enrollment in an interventional clinical study at the time of DMS Screening visit
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05227287
Start Date
January 20 2022
End Date
December 1 2028
Last Update
April 4 2025
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco (UCSF) - Benioff Children's Hospital - Oakland
Oakland, California, United States, 94609
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
4
Indiana University (IU) School of Medicine - University Hospital
Indianapolis, Indiana, United States, 46202