Pompe Lactation Sub-Registry

Genzyme

Status: Completed

Conditions: Pompe Disease; Glycogen Storage Disease

Treatments: Biological: alglucosidase alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT00566878

LTS13972 (Other Identifier)

AGLU03406

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Volunteers: No Healthy Volunteers

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