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Growth and Development Study of Alglucosidase Alfa | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT00486889

Growth and Development Study of Alglucosidase Alfa

Pompe disease (also known as glycogen storage disease Type II) is a rare autosomal recessive metabolic muscle disease caused by the deficiency of acid α glucosidase (GAA), an enzyme that degrades lyso...

Lead sponsor: Genzyme, a Sanofi Company•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Genzyme, a Sanofi Company

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•The participant or participant's legal guardian must have provided signed, informed consent prior to performing any study-related procedures.
•The participant must have had a confirmed diagnosis of Pompe disease as determined by deficient endogenous GAA activity or GAA mutation analysis.
•The participant must be less than (\<) 1 year of age at time of study enrollment (and received alglucosidase alfa treatment before 1 year of age), or the participant must be between 1 year and 24 months of age and must have had initiated alglucosidase alfa treatment prior to turning 1 year of age.

Exclusion Criteria

•The participant was participating in another clinical study using alglucosidase alfa or any investigational therapy.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 26, 2022Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment12

Start dateAug 2008

Last updatedAug 26, 2022

Condition

Pompe Disease Glycogen Storage Disease Type II (GSD-II)Acid Maltase Deficiency Disease

Locations shown

Gainesville, Florida

Decatur, Georgia

Detroit, Michigan

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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: August 26, 2022Data 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.

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