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NCT01597596 · ClinicalTrials.gov registry record · Phase 4
A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT01597596 is a Phase 4 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 4 participants.
The verdict
NCT01597596, a Phase 4 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who had been diagnosed with infantile-onset Pompe disease. Participants were treated with alglucosidase alfa 160 L scale product in the United States (US) and 4000 L scale product in the regions outside the US.
Interventions
- BIOLOGICAL alglucosidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01597596
The ClinicalTrials.gov registry entry for NCT01597596 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which alglucosidase alfa is the first listed.
NCT01597596 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01597596 about?
NCT01597596 is a clinical study titled "A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease". A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who had been diagnosed with infantile-onset Pompe disease. Participants were treated with alglucosidase alfa 160 L scale product in ...
What is the current status of trial NCT01597596?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2012-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01597596?
The interventions under investigation include: alglucosidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT01597596?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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