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Pompe Lactation Sub-Registry

CompletedN/A

Sponsor: Genzyme, a Sanofi Company

Conditions: Glycogen Storage Disease, Pompe Disease

Interventions: alglucosidase alfa

Countries: United States

The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease who receive alglucosidase alfa.

Eligibility overview

Sex: FEMALE

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Must be enrolled in Pompe Registry (NCT00231400)
* Must be pregnant and intend to breast-feed or be currently lactating and receive at least one infusion of alglucosidase alfa while lactating
* Provide a signed Patient Information and Authorization form to participate in the sub-registry prior to any sub-registry-related assessments are performed
* Agree to adhere to the sub-registry guidelines for antibody testing and recommended schedule of assessments.

Exclusion Criteria:

* Patients will be excluded from this sub-registry if they have received an investigational drug (excluding alglucosidase alfa in regions where alglucosidase alfa is not commercially available) within 30 days prior to Visit 1 breast milk collection

Locations (2)

Cambridge, Massachusetts, United States
Grand Rapids, Michigan, United States