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Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)

NCT00952484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-04-01

Study results available
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Summary

This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP compared to a historical control group.

Conditions

  • Hypophosphatasia (HPP)

Interventions

BIOLOGICAL

asfotase alfa

2 mg/kg subcutaneous injection three times per week for 6 months.

BIOLOGICAL

asfotase alfa

3 mg/kg subcutaneous injection three times per week for 6 months.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952484 on ClinicalTrials.gov