A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease

ClinicalTrials.gov ID: NCT01597596

Public ClinicalTrials.gov record NCT01597596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 21, 2026, 6:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3/4, Prospective, Multinational, Open-label, Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease

Study identification

NCT ID: NCT01597596
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 4
Lead sponsor: Genzyme, a Sanofi Company; Industry
Enrollment: 4 participants

Conditions and interventions

Conditions

Interventions

alglucosidase alfa Biological

Biological

Eligibility (public fields only)

Age range: Up to 12 Months
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 31, 2012
Primary completion: Nov 30, 2014
Completion: Nov 30, 2014
Last update posted: Jan 17, 2016

2012 – 2014

United States locations

U.S. sites: 14
U.S. states: 14
U.S. cities: 14

Facility	City	State	ZIP	Site status
Not listed	Little Rock	Arkansas	—	—
Not listed	Oakland	California	—	—
Not listed	Gainsville	Florida	—	—
Not listed	Decatur	Georgia	—	—
Not listed	Chicago	Illinois	—	—
Not listed	Cambridge	Massachusetts	—	—
Not listed	Detroit	Michigan	—	—
Not listed	Las Vegas	Nevada	—	—
Not listed	New Brunswick	New Jersey	—	—
Not listed	New York	New York	—	—
Not listed	Durham	North Carolina	—	—
Not listed	Cincinnati	Ohio	—	—
Not listed	Fort Worth	Texas	—	—
Not listed	Seattle	Washington	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01597596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 17, 2016 · Synced Jul 21, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01597596 live on ClinicalTrials.gov.

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