Evaluate Efficacy and Safety in Chinese Patients With Infantile-Onset Pompe Disease With One Year Alglucosidase Alfa Treatment

Exclusion Criteria

• •Patient who has previously been treated with acid alpha-glucosidase.
• •Patient who is participating in another clinical study using any investigational therapy.
• •Conditions/situations such as:
• •Clinical signs of cardiac failure with ejection fraction \< 40%.
• •Respiratory insufficiency (oxygen saturation \< 90% or carbon dioxide partial pressure \> 55 mm Hg \[venous\] or \> 40 mm hydrargyrum \[arterial\] in room air or any ventilator use).
• •Patients who are dependent on invasive or non-invasive ventilator support.
• •Patients with major congenital anomaly or clinically significant intercurrent organic disease unrelated to Pompe disease.
• •Patients not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.