Pompe Pregnancy Sub-Registry - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00567073

Purpose

The objective is to track pregnancy outcomes in women with Pompe Disease and to follow infants born to women with Pompe Disease.

Condition
Glycogen Storage Disease Type II (GSD II); Pompe Disease (Late-Onset); Glycongenesis 2 Acid Maltase Deficiency

Genetics Home Reference related topics: Pompe disease

Drug Information available for: Alglucosidase Alfa Glucan 1,4-alpha-Glucosidase

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Sub-Registry to Evaluate the Effect of Myozyme® (Alglucosidase Alfa) Treatment on Pregnancy and Infant Growth in Women With Pompe Disease

Further study details as provided by Genzyme:

Primary Outcome Measures:

To determine whether alglucosidase alfa is present 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 Myozyme. [ Designated as safety issue: No ]
To measure breast milk production and composition in women with Pompe disease who receive Myozyme. [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood

Study Start Date:

December 2007

Detailed Description:

Study Design Time Perspective: Retrospective and Prospective

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Enroll in or agree to enroll in Pompe Registry
Be pregnant or have been pregnant with appropriate medical documentation
Provide a signed Patient Information and Authorization Form to participate in the sub-registry prior to any sub-registry related data collection is performed

Exclusion Criteria:

No Exclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567073

Contacts

Contact: Medical Information	800-745-4447	MedInfo@genzyme.com
Contact: Medical Information	617-252-7832	MedInfo@genzyme.com

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Deborah Marsden, MD

Genzyme

More Information

Myozyme prescribing information This link exits the ClinicalTrials.gov site

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	AGLU03506
Study First Received:	December 1, 2007
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00567073
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Glycogen Storage Disease Type II (GSD-II)
GSD-II
Pompe Disease

Pompe Disease (Late-Onset)
Acid Maltase Deficiency Disease
Glycogenosis II

Study placed in the following topic categories:

Metabolic Diseases
Glycogen Storage Disease
Lysosomal Storage Diseases
Central Nervous System Diseases
Glycogen Storage Disease Type II
Brain Diseases
Glycogen storage disease type 2

Metabolism, Inborn Errors
Genetic Diseases, Inborn
Brain Diseases, Metabolic, Inborn
Metabolic disorder
Deficiency Diseases
Brain Diseases, Metabolic

Additional relevant MeSH terms:

Lysosomal Storage Diseases, Nervous System
Nervous System Diseases
Carbohydrate Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on January 16, 2009