Completed PHASE4 INTERVENTIONAL 1-arm NCT01288027

Exploratory Muscle Biopsy Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa

A Phase 4 Prospective Exploratory Muscle Biopsy, Biomarker, and Imaging Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa

Sponsor: Genzyme, a Sanofi Company

Conditions Glycogen Storage Disease Type II (GSD II) Glycogenesis 2 Acid Maltase Deficiency Pompe Disease (Late-Onset)

Interventions Alglucosidase Alfa

Updated 9 times since 2017 Last updated: Dec 4, 2014 Started: Jun 30, 2011 Primary completion: Dec 31, 2013 Completion: Dec 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Glycogen Storage Disease Type II (GSD II) and Glycogenesis 2 Acid Maltase Deficiency, this trial is completed. The trial is conducted by Genzyme, a Sanofi Company and has accumulated 9 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2023 — Jul 2024 [monthly]

Completed PHASE4
Dec 2022 — Jan 2023 [monthly]

Completed PHASE4

▶ Show 4 earlier versions

Jan 2021 — Dec 2022 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Jun 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Genzyme, a Sanofi Company

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Colombus, United States , Durham, United States , Fairfax, United States , Gainesville, United States , Heshey, United States , Kansas City, United States , Mainz, Germany , München, Germany , Münster, Germany , New York, United States and 5 more locations