Status:
COMPLETED
Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies.
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Pompe Disease Late-Onset
Glycogen Storage Disease Type II GSD II
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
Brief Summary
This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a Genzyme stud...
Eligibility Criteria
Inclusion
- Provide written informed consent prior to participating in any study related procedures;
- Currently enrolled in Protocol AGLU01402
- Have the ability to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time.
Exclusion
- Was pregnant or unwilling to use approved birth control during the course of the study;
- Had experienced any unmanageable AEs under Protocol AGLU01402 (as determined and agreed upon by the Principal Investigator and sponsor) due to rhGAA that would preclude continuing ERT;
- Was participating in any other investigational study.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00765414
Start Date
April 1 2003
End Date
August 1 2006
Last Update
February 5 2014
Active Locations (1)
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1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States