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NCT01163149 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)

A Phase 2 study, sponsored by Alexion Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT01163149 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 19 participants.

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The verdict

NCT01163149, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfotase alfa as compared to a control group to see effects on adolescents and adults with HPP.

Interventions

  • DRUG asfotase alfa

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2010-06
Est. Completion 2016-06
Phase Phase 2

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT01163149

The ClinicalTrials.gov registry entry for NCT01163149 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which asfotase alfa is the first listed.

NCT01163149 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01163149 about?

NCT01163149 is a clinical study titled "Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)". This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfota...

What is the current status of trial NCT01163149?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2010-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT01163149?

The interventions under investigation include: asfotase alfa (DRUG).

Who is sponsoring clinical trial NCT01163149?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.