Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2007-06-18
2034-01-31
Brief Summary
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The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Pompe disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with alglucosidase alfa or avalglucosidase alfa.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Pregnant women with confirmed diagnosis of Pompe Disease
No experimental intervention is given. Pregnant women with confirmed diagnosis of Pompe disease that are participating in the Pompe Registry (NCT00231400) and consented to participate in the Pompe Pregnancy Sub-registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglusidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated.
No interventions assigned to this group
Pregnant women receiving no treatment for Pompe disease
Pregnant women with Pompe disease enrolled in the Pompe disease registry (NCT00231400) who are not receiving treatment
No interventions assigned to this group
Infants born to mothers receiving treatment for Pompe disease
The infants of mothers with Pompe disease enrolled in the Pompe disease registry (NCT00231400) where the mothers are receiving treatment of alglucosidase alfa (Myozyme/Lumizyme) or avalglucosidase alfa (Nexviadyme/Nexviazyme)
No interventions assigned to this group
Infants born to mothers receiving no treatment for Pompe disease
The infants of mothers with Pompe disease enrolled in the Pompe Disease Registry (NCT00231400) where the mothers are not receiving Treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* be enrolled in the Pompe registry (NCT00231400)
* be pregnant, or have been pregnant with appropriate medical documentation available.
* provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.
Note: It is recommended that pregnancy data be collected on eligible women regardless of infant enrollment. In the event of patients having multiple pregnancies, participation in this Sub-Registry is encouraged for each individual pregnancy.
FEMALE
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Barrow Neurol Group- Site Number : 840087
Phoenix, Arizona, United States
Emory University School Of Medicine- Site Number : 840060
Atlanta, Georgia, United States
Indianapolis University School of Medicine- Site Number : 840027
Indianapolis, Indiana, United States
Spectrum for Health- Site Number : 840019
Grand Rapids, Michigan, United States
New York University School Of Medicine- Site Number : 840040
New York, New York, United States
Mt. Sinai School of Medicine- Site Number : 840005
New York, New York, United States
Duke University Medical Center Genetics Dept- Site Number : 840037
Durham, North Carolina, United States
LSD Data Registry Site LLC- Site Number : 840094
Dublin, Ohio, United States
Oregon Health and Science University- Site Number : 840095
Portland, Oregon, United States
O&O Alpan, LLC- Site Number : 840025
Fairfax, Virginia, United States
Investigational Site Number : 056001
Ghent, , Belgium
Investigational Site Number : 1910001
Zagreb, , Croatia
Investigational Site Number : 1910002
Zagreb, , Croatia
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 380008
Brescia, , Italy
Investigational Site Number : 380006
Cagliari, , Italy
Investigational Site Number : 380005
Florence, , Italy
Investigational Site Number : 380004
Genova, , Italy
Investigational Site Number : 380013
Messina, , Italy
Investigational Site Number : 380007
Milan, , Italy
Investigational Site Number : 380009
Monza, , Italy
Investigational Site Number : 380002
Padua, , Italy
Investigational Site Number : 380011
Padua, , Italy
Investigational Site Number : 380003
Pavia, , Italy
Investigational Site Number : 380015
Roma, , Italy
Investigational Site Number : 380012
Roma, , Italy
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Pompe Registry HelpLine
Role: CONTACT
Other Identifiers
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AGLU03506
Identifier Type: -
Identifier Source: org_study_id
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