Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
NCT05680818
Autosomal Dominant Hypocalcemia (ADH), Calcinosis
Oakland, California, United States
View Trial DetailsNCT Number: NCT05227287
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.
This study is active but is not currently recruiting participants.
Up to 90 year
All sexes
Observational
Royal North Shore Hospital, Saint Leonards, New South Wales, Australia
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 how standard of care treatment impacts ADH1 and ADH2 symptoms.
The study will include adult and pediatric participants with a confirmed clinical diagnosis of ADH1 or ADH2. Each participant's data will be collected over a period of up to 5 years. In addition, retrospective (or past) data will be collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Time frame: Up to 60 months
Calcilytix Therapeutics, Inc., a BridgeBio company
Industry
Autosomal Dominant Hypocalcemia Types 1 And 2 (ADH1/2) Disease Monitoring Study (DMS)
Acronym: CLARIFY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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