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RECRUITINGOBSERVATIONAL

Pompe Pregnancy Sub-Registry

A Sub-registry to Observe the Effect of Alglucosidase Alfa or Avalglucosidase Alfa Treatment on Pregnancy and Infant Growth in Women With Pompe Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Pompe Registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. 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.

Who May Be Eligible (Plain English)

Who May Qualify: Eligible women must: - be enrolled in the Pompe registry (NCT00231400) - be pregnant, or have been pregnant with appropriate medical documentation available. - provide a signed willing to sign a consent form 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. Who Should NOT Join This Trial: There are no exclusion criteria for this Sub-Registry Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Eligible women must: * 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. Exclusion Criteria: There are no exclusion criteria for this Sub-Registry

Locations (20)

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