Pompe Pregnancy Sub-Registry - Full Text View

Pompe Pregnancy Sub-Registry

This study is not yet open for participant recruitment.
Verified by Genzyme, November 2007

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
Pompe Disease

Genetics Home Reference related topics:

Pompe disease

ChemIDplus related topics:

Alglucosidase Alfa Glucan 1,4-alpha-Glucosidase

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other

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:

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

Study ID Numbers:	AGLU03506
First Received:	December 1, 2007
Last Updated:	December 1, 2007
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 October 03, 2008