Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.
NCT ID: NCT03794609
Last Updated: 2024-10-17
Study Results
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View full resultsBasic Information
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TERMINATED
315 participants
OBSERVATIONAL
2018-06-15
2023-01-13
Brief Summary
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Children's information will be collected in the registry for a maximum of 5 years.
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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. The child is able to provide written informed assent, where this is required according to national legislation, before any study related activity is carried out
3. The child has been diagnosed as having achondroplasia documented by clinical diagnosis
4. The child is between 0 years and 10 years of age, inclusive, on the date of consent / assent
5. The investigator has considered the family and prospective participating child being able to comply with the study procedures
Exclusion Criteria
2. The child has any medical condition that may impact growth or where the treatment is known to impact growth, such as but not limited to hypothyroidism or hyperthyroidism, insulin-requiring diabetes mellitus, autoimmune inflammatory disease (including celiac disease, systemic lupus erythematosus \[SLE\], juvenile dermatomyositis, scleroderma, and others), autonomic neuropathy, or inflammatory bowel disease
3. Treatment in the previous 12 months prior to consent and assent with growth hormone, insulin-like growth factor 1 (IGF-1), anabolic steroids, or any other drug expected to affect growth velocity
4. Any surgery that affects the growth plate of the long bones that is planned, or has occurred in the past 18 months
5. Participation in any interventional study (investigational product or device) for treatment of achondroplasia or short stature
6. Has had bone-related surgery impacting assessment of anthropometric measurements or is expected to have it during the study period. Children with previous limb-lengthening surgery may enroll if surgery occurred at least 18 months prior to the date of consent/assent and healing is complete without sequelae as determined by the investigator
7. Has any condition that in the view of the investigator places the child at high risk of poor compliance with the visit schedule or of not completing the study.
8. Any concurrent disease or condition that in the view of the investigator would interfere with study participation
0 Years
15 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Los Angeles Biomedical Research Institute At Harbour-UCLA Medical Centre
Los Angeles, California, United States
Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Alfred I. duPont Hospital for Children - Wilmington
Wilmington, Delaware, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
The John Hopkins
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Univesity of Missouri - Columbia
Columbia, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children Hospital
Houston, Texas, United States
Texas Children'S Hospital
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Murdoch Childrens Research Institute
Parkville, Victoria, Australia
Childrens Hospital Melbourne
Melbourne, , Australia
Antwerp University Hospital
Antwerp, , Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, , Belgium
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
The Hospital for Sick Children
Toronto, , Canada
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Righospitalet
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Centre Hospitalier Universitaire La Timone
Marseille, , France
Centre Hospitalier Univesitaire La Timone
Marseille, , France
Hopital Necker-Enfants Malades
Paris, , France
Center for Rare Skeletal Diseases in Childhood and Adolescence
Cologne, , Germany
University Hospital of Cologne
Cologne, , Germany
Otto-von-Guericke- Universitat Magdeburg
Magdeburg, , Germany
Otto-von-Guericke-Universitat Magdeburg
Magdeburg, , Germany
ASST Lariana Como
San Fermo della Battaglia, COMO, Italy
IRCCS Istituto Giannina Gaslini
Genova, Genoa, Italy
ASST Lariana Como
Como, , Italy
IRCCS Istituto Giannina Gaslini
Genova, , Italy
San Raffaele Hospital
Milan, , Italy
Center for Rare Diseases, Department of Pediatrics, Polo Salute Donna e Bambino
Rome, , Italy
Fondazione Policlinico Universitario A.Gemelli
Rome, , Italy
Osaka Women's and Children's Hospital
Izumi, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Okayama University Hospital
Okayama, , Japan
Hospital Pediatrico de Coimbra
Coimbra, , Portugal
Hospital Pediátrico de Coimbra
Coimbra, , Portugal
Vall d'Hebron University Hospital
Barcelona, , Spain
Vall D'Hebron Univeristy Hospital
Barcelona, , Spain
Hospital Quironsalud Malaga
Málaga, , Spain
CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS -CHUV Hôpital Neslé
Lausanne, , Switzerland
Centre Hospitalier Universitaire Vaudois -CHUV
Lausanne, , Switzerland
Bristol Royal Childrens Hospital
Bristol, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Guy's & St Thomas NHS Trust, St Thomas' Hospital
London, , United Kingdom
Guys & St Thomas NHS Trust
London, , United Kingdom
Newcastle Hospital NHS Foundation Trust
Newcastle, , United Kingdom
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, , United Kingdom
Sheffield Childrens NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4181001
Identifier Type: OTHER
Identifier Source: secondary_id
TA46-002
Identifier Type: -
Identifier Source: org_study_id
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