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Pompe Lactation Sub-Registry

This study is currently recruiting participants.
Verified October 2016 by Sanofi ( Genzyme, a Sanofi Company )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566878
First Posted: December 4, 2007
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
December 1, 2007
December 4, 2007
October 21, 2016
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 ]
  • breast milk production and composition in women with Pompe disease who receive alglucosidase alfa [ Time Frame: 6 Months ]
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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.
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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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: Medical Information 800-745-4447 MedInfo@genzyme.com
Contact: Medical Information 617-252-7832 MedInfo@genzyme.com
United States
 
 
NCT00566878
AGLU03406
LTS13972 ( Other Identifier: Sanofi )
No
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Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
October 2016