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NCT00567073 · ClinicalTrials.gov registry record
Pompe Pregnancy Sub-Registry
A clinical trial of Pompe Disease (Late-onset) and Glycogen Storage Disease Type II (GSD-II), sponsored by Genzyme, a Sanofi Company.
- Recruiting
- Registry status
- 20
- Enrollment target
- 20
- Study locations
NCT00567073 is a study of Pompe Disease (Late-onset) and Glycogen Storage Disease Type II (GSD-II) that is actively recruiting participants, run by Genzyme, a Sanofi Company. The registered enrollment target is 20 participants, below the 45-participant average among 8 other Pompe Disease (Late-onset) trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT00567073, a study of Pompe Disease (Late-onset) and Glycogen Storage Disease Type II (GSD-II), is actively recruiting participants, sponsored by Genzyme, a Sanofi Company.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 45-participant average among 8 other Pompe Disease (Late-onset) trials with a reported enrollment target (56% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pompe Disease (Late-onset) appearing as the primary indexed condition, and to 0 interventions.
NCT00567073 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, New York, Arizona.
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.
Who is sponsoring clinical trial NCT00567073?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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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