Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)

Completed · Phase 2

Conditions studied: Hypophosphatasia (HPP)

In brief

This clinical trial studies the long term safety and efficacy of asfotase alfa in children with HPP who completed Study ENB-006-09 (NCT00952484).

Key facts

Study ID

NCT01203826

Run by

Alexion Pharmaceuticals, Inc.

People needed

12

Starts

2010-04-01

Expected to finish

2016-06-01

Last updated by the study team

2019-03-13

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Compliant and satisfactory completion of Enobia-sponsored clinical trial ENB-006-09
• Written informed consent by parent or other legal guardian prior to any study procedures being performed
• Parent or other legal guardian willing to comply with study requirements

You may not qualify if…

• Clinically significant disease that precludes study participation, in the Investigator's opinion
• Treatment with an investigational drug other than asfotase alfa
• Enrollment in any study (other than ENB-006-09) involving an investigational drug, device, or treatment for HPP
• Prior treatment with bisphosphonates

Where it is running

• Shriners Hospital for Children — St Louis, Missouri, United States
• Children's Hospital Health Sciences Centre — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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