Pompe Lactation Sub-Registry

NCT00566878 — Completed, 2 participants, Genzyme, a Sanofi Company

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A Sub-Registry to Determine the Presence of Alglucosidase Alfa in Breast Milk From Women With Pompe Disease Treated With Alglucosidase Alfa.

Registry	NCT00566878
Status	Completed
Study type	Observational
Enrollment	2 (Actual)
Sponsor	Genzyme, a Sanofi Company (Industry)
Conditions	Glycogen Storage Disease, Pompe Disease
Interventions	alglucosidase alfa (Biological)
Dates	start 2012-03-31, primary completion 2024-02-09, completion 2024-02-09, first posted 2007-12-04, last updated 2024-03-19
Locations	2 sites in United States

-Summary

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.

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+Arms and interventions

alglucosidase alfa (Biological), also known as Myozyme, Lumizyme: At least one infusion of alglucosidase alfa post partum

+Outcome measures

Primary outcomes

alglucosidase alfa accumulation in immature (1-3 months post partum) or mature (4-6 months post partum) breast milk sample from mothers with Pompe disease who are being treated with alglucosidase alfa. [6 Months]
breast milk production and composition in women with Pompe disease who receive alglucosidase alfa [6 Months]

+Eligibility

Sex: Female

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)

Facility	City	Country	Status
Registry participation is worldwide. Facilities not yet active may enroll upon identification of a patient	Cambridge, Massachusetts	United States
	Grand Rapids, Michigan	United States

+Investigators

Medical Monitor, Study director, Genzyme, a Sanofi Company

My Notes

Public

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