Status:
COMPLETED
Late-Onset Treatment Study Extension Protocol
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Pompe Disease (Late-Onset)
Glycogen Storage Disease Type II (GSD-II)
Eligibility:
All Genders
8+ years
Phase:
PHASE4
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
- Patient must have completed protocol AGLU02704 (NCT00158600)
- Patient must provide signed, informed consent prior to performing any study-related procedures
- Patient (and patient's legal guardian if patient is under 18 years of age) must have the ability to comply with the clinical protocol
- A female patient of childbearing potential must have a negative pregnancy test at Baseline. (note: all female patients of childbearing potential and sexually mature males must use a medically accepted method of contraception throughout the study.)
Exclusion
- The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, would preclude treatment with alglucosidase alfa.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00455195
Start Date
March 1 2007
End Date
November 1 2008
Last Update
March 7 2014
Active Locations (31)
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1
Anchorage, Alaska, United States
2
Phoenix, Arizona, United States
3
Beverly Hills, California, United States
4
San Diego, California, United States