Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
95 participants
OBSERVATIONAL
2022-01-20
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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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.
* 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
Exclusion Criteria
* Enrollment in an interventional clinical study at the time of DMS Screening visit
90 Years
ALL
No
Sponsors
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Calcilytix Therapeutics, Inc., a BridgeBio company
INDUSTRY
Responsible Party
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Principal Investigators
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Calcilytix Medical Director
Role: STUDY_DIRECTOR
Calcilytix Therapeutics, Inc., a BridgeBio company
Locations
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University of California, San Francisco (UCSF) - Benioff Children's Hospital - Oakland
Oakland, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Indiana University (IU) School of Medicine - University Hospital
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Physician's East Endocrinology
Greenville, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Ohio State University Medical Center (OSUMC)
Columbus, Ohio, United States
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Universitaire Ziekenhuizen Leuven
Leuven, Flemish Brabant, Belgium
Bone Research and Education Centre
Oakville, Ontario, Canada
Aarhus University Hospital
Aarhus, , Denmark
Helsinki University Hospital (HUS) - The New Children's Hospital
Helsinki, , Finland
HCL Hopital Femme Mere Enfant
Bron, Auvergne-Rhône-Alpes, France
HCL Hopital Edouard Herriot
Lyon, Auvergne-Rhône-Alpes, France
CHU de Lille
Lille, , France
Departement d'Endocrinologie et Diabetes pour Enfants - AP-HP Hopital Bicetre
Le Kremlin-Bicêtre, Île-de-France Region, France
Endokrinologikum Gottingen
Göttingen, , Germany
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Policlinico Universitario Campus Bio-Medico
Rome, , Italy
Osaka University Hospital
Osaka, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Erasmus MC
Rotterdam, , Netherlands
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
Lisbon, , Portugal
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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CLTX-305-901
Identifier Type: -
Identifier Source: org_study_id
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