RecruitingNCT00567073

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


Sponsor

Genzyme, a Sanofi Company

Enrollment

20 participants

Start Date

Jun 18, 2007

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with glycogen storage disease type ii (gsd-ii), glycogenesis 2 acid maltase deficiency, and other related conditions. The study is currently recruiting participants at 35 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(35)

Barrow Neurol Group- Site Number : 840087

Phoenix, Arizona, United States

University of Florida Pediatrics Genetics- Site Number : 157138

Jacksonville, Florida, 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

University of Iowa- Site Number : 150294

Iowa City, Iowa, United States

Spectrum for Health- Site Number : 840019

Grand Rapids, Michigan, United States

Washington University- Site Number : 150612

St Louis, Missouri, 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

Columbia University Irving Medical Center- Site Number : 157199

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

Greenwood Genetic Center - Greenville- Site Number : 151184

Greenville, South Carolina, United States

O & O Alpan- Site Number : 840025

Fairfax, Virginia, United States

Investigational Site Number : 151069

Westmead, New South Wales, Australia

Investigational Site Number : 056001

Ghent, Belgium

Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 150978

São Paulo, Brazil

Investigational Site Number : 1910001

Zagreb, Croatia

Investigational Site Number : 1910002

Zagreb, Croatia

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 152200

Bonn, Germany

Investigational Site Number : 380005

Florence, Firenze, Italy

Investigational Site Number : 380007

Milan, Milano, Italy

Investigational Site Number : 380011

Padua, Padova, Italy

Investigational Site Number : 380015

Rome, Roma, Italy

Investigational Site Number : 380008

Brescia, Italy

Investigational Site Number : 380006

Cagliari, Italy

Investigational Site Number : 380004

Genova, Italy

Investigational Site Number : 380013

Messina, Italy

Investigational Site Number : 380009

Monza, Italy

Investigational Site Number : 380002

Padova, Italy

Investigational Site Number : 380003

Pavia, Italy

Investigational Site Number : 380012

Roma, Italy

Investigational Site Number : 87147

Cardiff, Cardiff [Caerdydd Gb-crd], United Kingdom

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