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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genzyme, a Sanofi Company
Age
16–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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.