Pompe Lactation Sub-Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/27/2017 |
| Start Date: | March 2012 |
| End Date: | December 2021 |
| Contact: | Medical Information |
| Email: | MedInfo@genzyme.com |
| Phone: | 800-745-4447 |
A Sub-Registry to Determine the Presence of Alglucosidase Alfa in Breast Milk From Women With Pompe Disease Treated With Alglucosidase Alfa.
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.
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.
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
We found this trial at
2
sites
Cambridge, Massachusetts 02142
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