Pompe Lactation Sub-Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00566878
First received: December 1, 2007
Last updated: October 21, 2014
Last verified: October 2014

December 1, 2007
October 21, 2014
March 2012
November 2021   (final data collection date for primary outcome measure)
  • 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. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • breast milk production and composition in women with Pompe disease who receive alglucosidase alfa [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00566878 on ClinicalTrials.gov Archive Site
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Pompe Lactation Sub-Registry
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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

Females diagnosed with Pompe Disease and Lactating

  • Glycogen Storage Disease
  • Pompe Disease
Biological: alglucosidase alfa
At least one infusion of alglucosidase alfa post partum
Other Names:
  • Myozyme
  • Lumizyme
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
December 2021
November 2021   (final data collection date for primary outcome measure)

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
Female
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No
Contact: Medical Information 800-745-4447 MedInfo@genzyme.com
Contact: Medical Information 617-252-7832 MedInfo@genzyme.com
United States
 
NCT00566878
AGLU03406, LTS13972
No
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP