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NCT01410890 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT01410890 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 21 participants.
The verdict
NCT01410890, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
* The primary objective of this study was to characterize the pharmacokinetics (PK) of alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed diagnosis of Pompe disease. * A secondary objective of this study was to evaluate and explore the relationship between anti-recombinant human acid alpha-glucosidase antibody titers and the PK of alglucosidase alfa.
Interventions
- BIOLOGICAL alglucosidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-11-03 |
| Est. Completion | 2020-11-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01410890
The ClinicalTrials.gov registry entry for NCT01410890 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 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.
NCT01410890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01410890 about?
NCT01410890 is a clinical study titled "Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease". * The primary objective of this study was to characterize the pharmacokinetics (PK) of alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed diagnosis of Pompe disease. * A secondary objective of this study was to evaluate and explore the relationship between anti-r...
What is the current status of trial NCT01410890?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2014-11-03. Estimated completion is 2020-11-20.
What interventions are being tested in trial NCT01410890?
The interventions under investigation include: alglucosidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT01410890?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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