Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.
NCT03794609
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Written informed consent is obtained from the children's parent(s) / legal guardian(s) before any study-related activity is carried out
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
1. The child has a diagnosis of hypochondroplasia or any short stature condition other
than achondroplasia (eg, spondyloepiphyseal dysplasia congenital [SEDC],
pseudoachondroplasia, trisomy 21)
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
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Descriptive Information | |||||
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Brief Title | Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia. | ||||
Official Title | A Multi-center, Prospective, Longitudinal, Observational Study to Investigate the Clinical and Anthropometric Characteristics of Children With the Diagnosis Achondroplasia. | ||||
Brief Summary | This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. Information collected will include in anthropometric characteristics, related symptoms, tests, & treatments Children's information will be collected in the registry for a maximum of 5 years. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | It is assumed that each of the study sites will enroll approximately 10-15 children of both genders and of various ages (0-10 years old). The total number of children planned to be enrolled across all sites is approximately 200. | ||||
Condition | Achondroplasia | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 15, 2023 | ||||
Estimated Primary Completion Date | June 15, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 10 Years (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Australia, Belgium, Canada, Denmark, France, Germany, Italy, Portugal, Spain, Switzerland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03794609 | ||||
Other Study ID Numbers | TA46-002 C4181001 ( Other Identifier: Pfizer ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | January 2021 |