This study is currently not recruiting participants.

Pompe Lactation Sub-Registry

Investigating the Presence of Investigational Medication in Breast Milk of Mothers with Pompe Disease

Not Recruiting
Female
Phase N/A
2 participants needed

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Glycogen Storage Disease, Pompe Disease
  • Gender: 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

This study investigates whether alglucosidase alfa is present in the breast milk of mothers with Pompe Disease.

This study evaluates the production and composition of breast milk in women with Pompe Disease who are treated with alglucosidase alfa.

  • Who can participate: Participants must be enrolled in the Pompe Registry and either pregnant and planning to breast-feed or currently lactating. They must receive at least one infusion of alglucosidase alfa while lactating.
  • Study details: Participants will provide breast milk samples to check for the presence of the investigational medication.
Updated on 19 Mar 2024. Study ID: NCT00566878