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Alglucosidase Alfa Pompe Safety Sub-Registry | Clinical Trials | Clareo Health

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COMPLETEDNCT01710813

Alglucosidase Alfa Pompe Safety Sub-Registry

To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated ...

Lead sponsor: Genzyme, a Sanofi Company•6 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Genzyme, a Sanofi Company

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•The patient must be enrolled in the Pompe Registry;
•Provide a signed patient information and authorization form;
•Have a confirmed diagnosis of Pompe disease (confirmation of diagnosis is defined as documented GAA enzyme deficiency from any tissue source and/or documentation of 2 GAA gene mutations);
•Be naïve to and plan to be treated with alglucosidase alfa at or prior to enrollment, or are being treated with alglucosidase alfa.

Exclusion Criteria

•Patients will be excluded if they have received an investigational drug (excluding alglucosidase alfa) within 30 days prior to signing a Safety Sub-Registry Patient Information and Authorization form, or if they are taking or plan to take any investigational product while enrolled in the Safety Sub-Registry.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 13, 2021Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment110

Start dateMar 2015

Last updatedJul 13, 2021

Condition

Locations shown

Investigational Site Number 840016

Phoenix, Arizona

Investigational Site Number 840002

Durham, North Carolina

Investigational Site Number 840004

Hershey, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2021Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions