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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02235493 |
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Date of registration:
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05/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09
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Scientific title:
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A Single-Center, Non-interventional Substudy of ALX-HPP-502 to Assess Functional Natural History Data of Patients With Juvenile Historical Controls in ENB-006-09 |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02235493 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented informed consent/assent prior to video collection and data abstraction.
- Documented informed consent/assent in Study ALX-HPP-502.
- Patients with juvenile-onset HPP and was selected as a historical-control for Study
ENB-006-09.
- Patients with at least 2 videos of basic mobility that were recorded at 2 different
clinic visits when the patient was =5 to =15 ye
Exclusion Criteria:
- There are no exclusion criteria for this study
Age minimum:
5 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypophosphatasia
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Bone Disease
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Intervention(s)
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Biological: Retrospective Case Only
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Primary Outcome(s)
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Modified Performance-Oriented Mobility Assessment-Gait Subtest (MPOMA-G) - Change From Baseline to Last Overall
[Time Frame: The earliest available MPOMA-G score that was assessed within the period of patients' aged 5 to 15 years, inclusive.]
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Secondary Outcome(s)
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Performance-Oriented Mobility Assessment-Gait Subtest (POMA-G) - Change From Baseline to Last Overall
[Time Frame: The earliest available MPOMA-G score that was assessed within the period of patients' aged 5 to 15 years, inclusive.]
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Secondary ID(s)
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ALX-HPP-502s
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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