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NCT01526785 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 4
- Development phase
- 113
- Enrollment target
NCT01526785: Clinical Trial Phase 4 study, sponsored by Genzyme, a Sanofi Company.
NCT01526785 is a Phase 4 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 113 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526785, a Phase 4 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 113 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.
Primary Outcome
Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.
Interventions
- DRUG Alglucosidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
Why NCT01526785 stopped before completion
NCT01526785 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Alglucosidase alfa is the first listed.
NCT01526785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526785 about?
NCT01526785 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease". The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.
What is the current status of trial NCT01526785?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 113 participants. The study started on 2012-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01526785?
The interventions under investigation include: Alglucosidase alfa (DRUG).
Who is sponsoring clinical trial NCT01526785?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526785's enrollment target sits among peer trials
113 723rd of 2000 higher than 1,277 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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