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

Completed · Phase 2

Conditions studied: Hypophosphatasia

In brief

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).

Key facts

Study ID

NCT01205152

Run by

Alexion Pharmaceuticals, Inc.

People needed

10

Starts

2009-04-01

Expected to finish

2016-08-01

Last updated by the study team

2019-03-13

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient completed participation in ENB-002-08 (NCT00744042)
• 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…

• History of sensitivity to any of the constituents of the study drug
• Clinically significant disease that precludes study participation
• Enrollment in any study (other than ENB-002-08) involving an investigational drug, device, or treatment for HPP (e.g., bone marrow transplantation)

Where it is running

• Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States
• St. John's Medical Research Institute — Springfield, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• St. Vincent Hospital — Green Bay, Wisconsin, United States
• Tawam Hospital — Al Ain City, Abu Dhabi Emirate, United Arab Emirates
• Royal Maternity Hospital, Royal Belfast Hospital for Sick Children — Belfast, Northern Ireland, United Kingdom
• Sheffield Children's Hospital — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.