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NCT00567073Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
1 Dec 2007
Start date
18 Jun 2007
Primary completion date
31 Jan 2034
Lead sponsor
Genzyme, a Sanofi Company
NCT number
NCT00567073

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 18 Jun 2007 to the primary completion date, 31 Jan 2034
  • 35 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • There are no exclusion criteria for this Sub-Registry

Who the study is looking for

  • 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.

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
WestmeadAustraliaRecruiting
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Coordinator of this site? Confirm its status
GhentBelgiumRecruiting
Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 150978
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
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Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
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Coordinator of this site? Confirm its status
BonnGermanyRecruiting
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Coordinator of this site? Confirm its status
CardiffUnited KingdomRecruiting
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Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting
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Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting
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Coordinator of this site? Confirm its status
BresciaItalyRecruiting
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Coordinator of this site? Confirm its status
CagliariItalyRecruiting
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Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
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Coordinator of this site? Confirm its status
GenovaItalyRecruiting
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Coordinator of this site? Confirm its status
MessinaItalyRecruiting
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Coordinator of this site? Confirm its status
MilanItalyRecruiting
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Coordinator of this site? Confirm its status
MonzaItalyRecruiting
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Coordinator of this site? Confirm its status
PadovaItalyRecruiting
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Coordinator of this site? Confirm its status
PaduaItalyRecruiting
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Coordinator of this site? Confirm its status
PaviaItalyRecruiting
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Coordinator of this site? Confirm its status
RomaItalyRecruiting
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Coordinator of this site? Confirm its status
RomeItalyRecruiting
Emory University School Of Medicine- Site Number : 840060
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Lsd Data Registry Site Llc- Site Number : 840094
Coordinator of this site? Confirm its status
DublinUnited StatesRecruiting
Duke University Medical Center Genetics Dept- Site Number : 840037
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
O & O Alpan- Site Number : 840025
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Spectrum for Health- Site Number : 840019
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Greenwood Genetic Center - Greenville- Site Number : 151184
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
Indianapolis University School Of Medicine- Site Number : 840027
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
University of Iowa- Site Number : 150294
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
University of Florida Pediatrics Genetics- Site Number : 157138
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Mt. Sinai School of Medicine- Site Number : 840005
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Columbia University Irving Medical Center- Site Number : 157199
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
New York University School Of Medicine- Site Number : 840040
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
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Coordinator of this site? Confirm its status
PhoenixUnited StatesRecruiting
Oregon Health and Science University- Site Number : 840095
Coordinator of this site? Confirm its status
PortlandUnited StatesCompleted
Washington University- Site Number : 150612
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.