A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia
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ClinicalTrials.gov Identifier: NCT03875534 |
Recruitment Status :
Recruiting
First Posted : March 14, 2019
Last Update Posted : November 29, 2022
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Sponsor:
Ascendis Pharma A/S
Information provided by (Responsible Party):
Ascendis Pharma A/S
Tracking Information | |||||
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First Submitted Date | March 7, 2019 | ||||
First Posted Date | March 14, 2019 | ||||
Last Update Posted Date | November 29, 2022 | ||||
Actual Study Start Date | June 19, 2019 | ||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Annualized height velocity (centimeters/year) in children with achondroplasia [ Time Frame: Up to 5 years ] Subjects will undergo a series of height measurements (in centimeters) on Day 1 and then every 6 months over the study period with height velocity reported in cm/year
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
Collection of natural history of achondroplasia symptoms in children with achondroplasia [ Time Frame: Up to 5 years ] To characterize achondroplasia symptoms in children with achondroplasia
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia | ||||
Official Title | ACHieve: A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia | ||||
Brief Summary | This is a long-term, multi-center, longitudinal, observational study in children with achondroplasia (ACH). The aim is to study height velocity and comorbidities in children with ACH. This is a natural history study and no study medication will be administered. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Infants and children with achondroplasia from birth to 8 years of age. | ||||
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. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | June 2024 | ||||
Estimated Primary Completion Date | June 2024 (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 | 0 Years to 8 Years (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Australia, Austria, Canada, China, Denmark, France, Germany, Ireland, Italy, New Zealand, Portugal, Spain, Switzerland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03875534 | ||||
Other Study ID Numbers | TCC-NHS-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Ascendis Pharma A/S | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Ascendis Pharma A/S | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Ascendis Pharma A/S | ||||
Verification Date | November 2022 |