Sponsor study identifier
observational
32
8 countries
19
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 25, 2014
Actual (reported)April 4, 2014
Actual (reported)September 2014
Actual (reported)September 2014
Actual (reported)December 18, 2015
Actual (reported)Radiographic Global Impression of Change - RGI-C
The RGI-C scale is a 7-point ordinal scale that is used to evaluate musculoskeletal characteristics of HPP (eg, metaphyseal fraying, demineralization of distal metaphyses). The scores range from -3 (severe worsening) to +3 (complete or near-complete healing).
Between Baseline (earliest available, complete, and readable x-ray set) and all available, readable post-Baseline x-ray sets during the period of patients' aged 5 to 15 years, inclusive.
Change in Height Z-score From Baseline to Last Assessment
Any available growth data during the period of patients' aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while post baselines are time points after Baseline during the defined age period.
Change in Weight Z-score From Baseline to Last Assessment
Any available growth data during the period of patients' aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while Post baselines are time points after Baseline during the defined age period.
Rickets Severity Sale - RSS
Any available data during the period of patients' aged 5 to 15 years, inclusive. Baseline is the earliest available assessment value during the period.
Juvenile-onset HPP (≥ 6 months and ˂18 years)
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
32 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2014
First Posted
April 4, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
Contact the study team to confirm eligibility.
Houston, Texas, United States
Seattle, Washington, United States
Sydney, Australia
Winnipeg, Manitoba, Canada
Le Kremlin-Bicêtre, France
Paris, France
Toulouse, France
Rotterdam, Netherlands
Moscow, Russia
Istanbul, Turkey (Türkiye)
Manchester, United Kingdom
Sheffield, United Kingdom
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
April 1, 2019
Results First Posted
December 18, 2015
Record last verified: 2019-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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