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NCT01205152 · ClinicalTrials.gov registry record · Phase 2

Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)

A Phase 2 study of Hypophosphatasia, sponsored by Alexion Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target
8
Study locations

NCT01205152 is a Phase 2 study of Hypophosphatasia that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 10 participants, below the 82-participant average among 6 other Hypophosphatasia trials with a reported enrollment target (88% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT01205152, a Phase 2 study of Hypophosphatasia, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target
8
Study locations

Study Summary

This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042). Partial funding for this study was provided by the Office of Orphan Product Development (OOPD).

Conditions Studied

Interventions

  • BIOLOGICAL asfotase alfa

Study Locations (8)

Delaware

  • Alfred I. DuPont Hospital for Children - Wilmington

Missouri

  • St. John's Medical Research Institute - Springfield

Nebraska

  • University of Nebraska Medical Center - Omaha

Tennessee

  • Vanderbilt University Medical Center - Nashville

Wisconsin

  • St. Vincent Hospital - Green Bay

Abu Dhabi Emirate

  • Tawam Hospital - Al Ain City

Northern Ireland

  • Royal Maternity Hospital, Royal Belfast Hospital for Sick Children - Belfast

Other

  • Sheffield Children's Hospital - Sheffield

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-04
Est. Completion 2016-08
Phase Phase 2

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT01205152

The ClinicalTrials.gov registry entry for NCT01205152 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 6 other Hypophosphatasia trials with a reported enrollment target (88% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypophosphatasia appearing as the primary indexed condition, and to 1 intervention - of which asfotase alfa is the first listed.

NCT01205152 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Delaware, Missouri, Nebraska.

Frequently Asked Questions

What is clinical trial NCT01205152 about?

NCT01205152 is a clinical study titled "Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)". This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042). Partial funding for this study was provided by the Office of Orphan Product Development (OOPD).

What is the current status of trial NCT01205152?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2009-04. Estimated completion is 2016-08.

What conditions does trial NCT01205152 study?

This clinical trial studies the following conditions: Hypophosphatasia.

What interventions are being tested in trial NCT01205152?

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

Who is sponsoring clinical trial NCT01205152?

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

Where is trial NCT01205152 being conducted?

This trial has 8 study locations across Delaware, Missouri, Nebraska, Tennessee, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.