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
- Diseases
- Pompe disease
- 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
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 150978 Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| - Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| - Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| - Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Padua | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Emory University School Of Medicine- Site Number : 840060 Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Lsd Data Registry Site Llc- Site Number : 840094 Coordinator of this site? Confirm its status | Dublin | United States | Recruiting |
| Duke University Medical Center Genetics Dept- Site Number : 840037 Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| O & O Alpan- Site Number : 840025 Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Spectrum for Health- Site Number : 840019 Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Greenwood Genetic Center - Greenville- Site Number : 151184 Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Indianapolis University School Of Medicine- Site Number : 840027 Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Iowa- Site Number : 150294 Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Florida Pediatrics Genetics- Site Number : 157138 Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Mt. Sinai School of Medicine- Site Number : 840005 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Irving Medical Center- Site Number : 157199 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| New York University School Of Medicine- Site Number : 840040 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Oregon Health and Science University- Site Number : 840095 Coordinator of this site? Confirm its status | Portland | United States | Completed |
| Washington University- Site Number : 150612 Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.