Lead Sponsor

Genzyme, a Sanofi Company

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

No

•The participant's parent/legal guardian was willing and able to provide signed informed consent.
•The participant might be less than or equal to 12 months of age.
•The participant might have documented GAA enzyme deficiency from blood, skin, or muscle tissue.
•The participant might be naïve to treatment with alglucosidase alfa.

•The participant was cross-reactive immunologic material negative.
•The participant required invasive ventilator support at the time of enrollment.
•The participant had decompensated clinical heart failure.
•The participant had a major congenital abnormality, excluding cardiac hypertrophy.
•The participant had a clinically significant organ disease (excluding the signs and symptoms of Pompe disease).
•The participant was currently receiving any investigational product.
•The participant was participating in another clinical study.
•The participant and/or the patient's parent/legal guardian was unable to adhere to the requirements of the study.

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