Status:
COMPLETED
Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Glycogen Storage Disease Type II
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells...
Eligibility Criteria
Inclusion
- The patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed
- The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol
- The patient must have completed Protocol AGLU01602.
Exclusion
- Patient has experienced any unmanageable adverse event (AE) in Protocol AGLU01602 due to Myozyme that would preclude continuing treatment with Myozyme
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00125879
Start Date
June 1 2005
End Date
December 1 2006
Last Update
February 6 2014
Active Locations (14)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
3
Miami Children's Hospital
Miami, Florida, United States, 33155
4
Emory University Medical Genetics
Decatur, Georgia, United States, 30033