Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Pompe Pregnancy Sub-Registry
NCT00567073 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (20)
Other
- Investigational Site Number : 056001 — Ghent
- Investigational Site Number : 1910001 — Zagreb
- Investigational Site Number : 1910002 — Zagreb
- Investigational Site Number : 2030001 — Prague
- Investigational Site Number : 380008 — Brescia
- Investigational Site Number : 380006 — Cagliari
- Investigational Site Number : 380005 — Florence
- Investigational Site Number : 380004 — Genova
- Investigational Site Number : 380013 — Messina
- Investigational Site Number : 380007 — Milan
New York
- New York University School Of Medicine- Site Number : 840040 — New York
- Mt. Sinai School of Medicine- Site Number : 840005 — New York
Arizona
- Barrow Neurol Group- Site Number : 840087 — Phoenix
Georgia
- Emory University School Of Medicine- Site Number : 840060 — Atlanta
Indiana
- Indianapolis University School of Medicine- Site Number : 840027 — Indianapolis
Michigan
- Spectrum for Health- Site Number : 840019 — Grand Rapids
North Carolina
- Duke University Medical Center Genetics Dept- Site Number : 840037 — Durham
Ohio
- LSD Data Registry Site LLC- Site Number : 840094 — Dublin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-06-18 |
| Est. Completion | 2034-01-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00567073
The ClinicalTrials.gov registry entry for NCT00567073 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pompe Disease (Late-onset) appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00567073 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00567073 about?
NCT00567073 is a clinical study titled "Pompe Pregnancy Sub-Registry". 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 av...
What is the current status of trial NCT00567073?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2007-06-18. Estimated completion is 2034-01-31.
What conditions does trial NCT00567073 study?
This clinical trial studies the following conditions: Pompe Disease (Late-onset), Glycogen Storage Disease Type II (GSD-II), Glycogenesis 2 Acid Maltase Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00567073?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00567073 being conducted?
This trial has 20 study locations across Arizona, Georgia, Indiana, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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