Prospective Clinical Assessment Study in Children With Hypochondroplasia
NCT ID: NCT06410976
Last Updated: 2025-10-10
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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RECRUITING
150 participants
OBSERVATIONAL
2024-06-05
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Aged 2.5 to \<17 years at study entry.
Diagnosis of HCH documented clinically by the presence of disproportionate short stature and confirmed with a molecular test.
Participants are ambulatory and able to stand without assistance.
Study participants and parent(s), guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures.
Exclusion Criteria
In females, having had their menarche. Annualized height growth velocity ≤1.5 cm/year over a period ≥6 months prior to screening.
Having a clinically significant disease or condition that in view of the investigator or Sponsor will interfere with the evaluation of growth, with study participation or not be in the best interest of the participant.
Clinically significant abnormality in any laboratory test result at screening
Current evidence of corneal or retinal disorders.
Have used any other investigational or approved product or medical device for the treatment of HCH or short stature for ≥ 30 days or with the last dose \<6 months before screening.
Have had regular long-term treatment (\>1 month) with oral corticosteroids (low-dose ongoing inhaled steroid for asthma is acceptable).
Previous limb-lengthening surgery or guided growth surgery with plates still in place or removed within the 6 months prior to screening.
Having had a fracture of the long bones or spine within 12 months of screening.
History and/or current evidence of extensive ectopic tissue calcification.
History of malignancy.
Concurrent circumstance, disease, or condition that, in the view of the investigator and/or sponsor, would interfere with study participation, and/or would place the participant at high risk for poor compliance with study activities or for not completing the study.
Current participation in any other ongoing clinical study with another sponsor.
30 Months
16 Years
ALL
No
Sponsors
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QED Therapeutics, Inc., a Bridgebio company
INDUSTRY
Responsible Party
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Locations
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UCSF Benioff Children's Hospital
Oakland, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
University of Missouri
Columbia, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic
Madison, Wisconsin, United States
Murdoch Children's Research Institute
Parkville, Victoria, Australia
London Health Sciences Centre - Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, Canada
Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Hôpital Femme Mère Enfant HCL
Bron, , France
Hôpital Necker-Enfants Malades
Paris, , France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants
Toulouse, , France
Haukeland University Hospital
Bergen, , Norway
Paediatric Clinical Research Unit at Oslo University Hospital
Oslo, , Norway
Hospital Pediátrico de Coimbra
Coimbra, , Portugal
KK Women's and Children's Hospital
Singapore, , Singapore
Hospital Vithas San Jose
Vitoria-Gasteiz, , Spain
Astrid Lindgren Children's Hospital
Solna, , Sweden
The Portland Hospital for Women and Children
London, England, United Kingdom
Manchester University
Manchester, England, United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, England, United Kingdom
Glasgow Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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QBGJ398-004
Identifier Type: -
Identifier Source: org_study_id
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