Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)

NCT ID: NCT02104219

Last Updated: 2019-04-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.

Detailed Description

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Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are no approved disease-modifying treatments for patients with this disease. There is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Conditions

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Hypophosphatasia (HPP)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Documented informed consent unless patient is deceased
* Patients with Juvenile-onset HPP, defined as documented onset of first signs/symptoms at ≥ 6 months to ˂18 years
* Documented diagnosis of HPP as indicated by skeletal manifestations and low alkaline phosphatase or genotyping

Exclusion Criteria

* Received treatment with asfotase alfa in the ENB-006-09 study and/or currently enrolled in the ENB-008-10 study
* Received other treatment and/or intervention to treat HPP up to 15 years old
* Other clinically significant disease
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlanta, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Boston, Massachusetts, United States

Site Status

Springfield, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Durham, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Houston, Texas, United States

Site Status

Seattle, Washington, United States

Site Status

Sydney, , Australia

Site Status

Winnipeg, Manitoba, Canada

Site Status

Le Kremlin-Bicêtre, , France

Site Status

Paris, , France

Site Status

Toulouse, , France

Site Status

Rotterdam, , Netherlands

Site Status

Moscow, , Russia

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Manchester, , United Kingdom

Site Status

Sheffield, , United Kingdom

Site Status

Countries

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United States Australia Canada France Netherlands Russia Turkey (Türkiye) United Kingdom

Related Links

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http://www.hypophosphatasia.com

Hypophosphatasia Website

http://www.hypophosphatasia.com/hcp/

Hypophosphatasia Website for Health Care Professionals

http://www.softbones.org

US Hypophosphatasia Group (Soft Bones)

Other Identifiers

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ALX-HPP-502

Identifier Type: -

Identifier Source: org_study_id

NCT02104206

Identifier Type: -

Identifier Source: nct_alias

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