CompletedNot Applicable

Pompe Lactation Sub-Registry

United States2 participantsStarted 2012-03-31

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 6 Months

breast milk production and composition in women with Pompe disease who receive alglucosidase alfa

Timeframe: 6 Months

Trial details

NCT IDNCT00566878

SponsorGenzyme, a Sanofi Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-09

View on ClinicalTrials.gov More Glycogen Storage Disease trials