Pompe Pregnancy Sub-Registry

Recruiting now

Conditions studied: Glycogen Storage Disease Type II (GSD-II), Pompe Disease (Late-onset), Glycogenesis 2 Acid Maltase Deficiency

In brief

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.

Key facts

Study ID

NCT00567073

Run by

Genzyme, a Sanofi Company

People needed

20

Starts

2007-06-18

Expected to finish

2034-01-31

Last updated by the study team

2026-04-16

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no exclusion criteria for this Sub-Registry

Where it is running

• Investigational Site Number : 87147 — Cardiff, Cardiff [Caerdydd Gb-crd], United Kingdom (enrolling)
• University of Florida Pediatrics Genetics- Site Number : 157138 — Jacksonville, Florida, United States (enrolling)
• Emory University School Of Medicine- Site Number : 840060 — Atlanta, Georgia, United States (enrolling)
• Indianapolis University School of Medicine- Site Number : 840027 — Indianapolis, Indiana, United States (enrolling)
• University of Iowa- Site Number : 150294 — Iowa City, Iowa, United States (enrolling)
• Spectrum for Health- Site Number : 840019 — Grand Rapids, Michigan, United States (enrolling)
• Washington University- Site Number : 150612 — St Louis, Missouri, United States (enrolling)
• New York University School Of Medicine- Site Number : 840040 — New York, New York, United States (enrolling)
• Mt. Sinai School of Medicine- Site Number : 840005 — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center- Site Number : 157199 — New York, New York, United States (enrolling)
• Duke University Medical Center Genetics Dept- Site Number : 840037 — Durham, North Carolina, United States (enrolling)
• LSD Data Registry Site LLC- Site Number : 840094 — Dublin, Ohio, United States (enrolling)
• Barrow Neurol Group- Site Number : 840087 — Phoenix, Arizona, United States (enrolling)
• Greenwood Genetic Center - Greenville- Site Number : 151184 — Greenville, South Carolina, United States (enrolling)
• O & O Alpan- Site Number : 840025 — Fairfax, Virginia, United States (enrolling)
• Investigational Site Number : 151069 — Westmead, New South Wales, Australia (enrolling)
• Investigational Site Number : 056001 — Ghent, Belgium (enrolling)
• Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 150978 — São Paulo, Brazil (enrolling)
• Investigational Site Number : 1910001 — Zagreb, Croatia (enrolling)
• Investigational Site Number : 1910002 — Zagreb, Croatia (enrolling)
• Investigational Site Number : 2030001 — Prague, Czechia (enrolling)
• Investigational Site Number : 152200 — Bonn, Germany (enrolling)
• Investigational Site Number : 380005 — Florence, Firenze, Italy (enrolling)
• Investigational Site Number : 380007 — Milan, Milano, Italy (enrolling)
• Investigational Site Number : 380011 — Padua, Padova, Italy (enrolling)

Full record on ClinicalTrials.gov

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