A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia
NCT ID: NCT03875534
Last Updated: 2024-03-19
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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COMPLETED
260 participants
OBSERVATIONAL
2019-06-19
2024-01-12
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
2. Willing and able to comply with study protocol per investigator judgement
3. Clinical diagnosis of achondroplasia (confirmed by the investigator)
4. Age between 0 to 8 years old at enrollment
5. Able to stand without assistance (if the child is 24 months or older)
Exclusion Criteria
2. Have received any dose of medicinal products intended to affect stature or body proportionality within the previous 6 months of screening
3. Have received any investigational medicinal product or device intended to affect stature or body proportionality at any time
4. History or presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones
5. History of any bone-related surgery that affects growth potential of long bones, such as orthopedic reconstructive surgery and osteotomy (foramen magnum decompression, and laminectomy with full recovery are allowed with minimum of 6 months of bone healing. Limb-lengthening with full recovery is allowed with a minimum of 12 months of bone healing.)
6. Have forms of skeletal dysplasias other than achondroplasia or medical conditions that result in short stature or abnormal bone growth \[such as severe achondroplasia with developmental delay and acanthosis nigricans (SADDAN), hypochondroplasia, growth hormone deficiency, Turner syndrome, pseudoachondroplasia. uncontrolled hypothyroidism, uncontrolled diabetes mellitus, autoimmune disease requiring corticosteroid therapy, inflammatory bowel disease, and chronic renal insufficiency\]
7. History or presence of malignant disease, other than basal cell epithelioma/carcinoma or completely resected squamous skin cancer with no recurrence for 12 months per medical records
0 Years
8 Years
ALL
No
Sponsors
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Ascendis Pharma A/S
INDUSTRY
Responsible Party
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Locations
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Ascendis Pharma Investigational Site
Little Rock, Arkansas, United States
Ascendis Pharma Investigational Site
Oakland, California, United States
Ascendis Pharma Investigational Site
Aurora, Colorado, United States
Ascendis Pharma Investigational Site
Wilmington, Delaware, United States
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, United States
Ascendis Pharma Investigational Site
Columbia, Missouri, United States
Ascendis Pharma Investigational Site
Buffalo, New York, United States
Ascendis Pharma Investigational Site
Houston, Texas, United States
Ascendis Pharma Investigational Site
Seattle, Washington, United States
Ascendis Pharma Investigational Site
Madison, Wisconsin, United States
Ascendis Pharma Investigational Site
Parkville, Victoria, Australia
Ascendis Pharma Investigational Site
Linz, , Austria
Ascendis Pharma Investigational Site
Edmonton, Alberta, Canada
Ascendis Pharma Investigational Site
Ottawa, Ontario, Canada
Ascendis Pharma Investigational Site
Montreal, Quebec, Canada
Ascendis Pharma Investigational Site
Beijing, , China
Ascendis Pharma Investigational Site
Guangzhou, , China
Ascendis Pharma Investigational Site
Hangzhou, , China
Ascendis Pharma Investigational Site
Shanghai, , China
Ascendis Pharma Investigational Site
Shenzhen, , China
Ascendis Pharma Investigational Site
Wuhan, , China
Ascendis Pharma Investigational Site
Copenhagen, Capital Region, Denmark
Ascendis Pharma Investigational Site
Paris, , France
Ascendis Pharma Investigational Site
Berlin, , Germany
Ascendis Pharma Investigational Site
Dublin, , Ireland
Ascendis Pharma Investigational Site
Milan, , Italy
Ascendis Pharma Investigational Site
Auckland, , New Zealand
Ascendis Pharma Investigational Site
Coimbra, , Portugal
Ascendis Pharma Investigational Site
Barcelona, , Spain
Ascendis Pharma Investigational Site
Esplugues de Llobregat, , Spain
Ascendis Pharma Investigational Site
Madrid, , Spain
Ascendis Pharma Investigational Site
Vitoria-Gasteiz, , Spain
Ascendis Pharma Investigational Site
Lausanne, , Switzerland
Ascendis Pharma Investigational Site
Glasgow, , United Kingdom
Ascendis Pharma Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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TCC-NHS-01
Identifier Type: -
Identifier Source: org_study_id
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