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

> **NCT01597596** · PHASE4 · TERMINATED · sponsor: **Genzyme, a Sanofi Company** · enrollment: 4 (actual)

## Conditions studied

- Pompe Disease (Infantile-Onset)
- Glycogen Storage Disease Type II (GSD II)
- Glycogenosis 2
- Acid Maltase Deficiency

## Interventions

- **BIOLOGICAL:** alglucosidase alfa
- **BIOLOGICAL:** alglucosidase alfa

## Key facts

- **NCT ID:** NCT01597596
- **Lead sponsor:** Genzyme, a Sanofi Company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2012-08
- **Primary completion:** 2014-12
- **Final completion:** 2014-12
- **Target enrollment:** 4 (ACTUAL)
- **Why stopped:** Study was stopped due to approved label expansion of alglucosidase alfa.
- **Last updated:** 2016-01-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01597596

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01597596, "A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01597596. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*