Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen

Inclusion criteria :

• Patients (or and patient's legal guardian) must provide written informed consentprior to any study-related procedures

• The patient must be ≥ 3 years of age at the time of enrollment.

1. For patient ≥ 3-year and < 5-year old: must be able to walk 10 meters or climb 4-step stairs independently.

2. For patients ≥5-year old i. Must be able to ambulate 40 meters in 6 minutes without assistance ii. Must beable to successfully perform repeated forced vital capacity (VC) measurements inupright position of ≥ 30% predicted and ≤85% predicted.

• The patient has confirmed Pompe's Disease with at least 2 of the followingcondition,

1. GAA enzyme deficiency from any tissue source.

2. 2 confirmed GAA gene mutations.

3. muscle pathology meet the diagnosis of Pompe disease.

• The patient (and patient's legal guardian if patient is legally minor as defined bylocal regulation) must have the ability to comply with the clinical protocol.

• The patient, if female and of childbearing potential, must have a negative pregnancytest (beta-human chorionic gonadotropin) at baseline.

Exclusion criteria:

• Use of invasive ventilatory support (Invasive ventilation is defined as any form ofventilatory support applied with the use of an endotracheal tube.)

• Use of non-invasive ventilatory support while awake and in an upright position. (Non-invasive ventilation is defined as any form of ventilatory support appliedwithout the use of an endotracheal tube.)

• Previously treated with Enzyme Replacement Treatment.

• A Female patient of childbearing potential with a positive pregnancy test.

• Wheelchair dependent.

• The patient has a major congenital anomaly.

• The patient has a medical condition, serious intercurrent illness, or otherextenuating circumstance, in the opinion of the Investigator, may significantlyinterfere with study compliance, including all prescribed evaluations and follow-upactivities.

• The patients with ≥5-year old are unable to ambulate 40 meters without assistance orunable to successfully perform repeated FVC of >30% and <85% predicted (upright).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.