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NCT00701415 · ClinicalTrials.gov registry record · Phase 3
A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT00701415 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 31 participants.
The verdict
NCT00701415, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without severe symptoms. Participants were to be treated for 5 years.
Interventions
- BIOLOGICAL Agalsidase beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00701415
The ClinicalTrials.gov registry entry for NCT00701415 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 31 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 Agalsidase beta is the first listed.
NCT00701415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00701415 about?
NCT00701415 is a clinical study titled "A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms". The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without severe symptoms. Participants were to be treated for 5 years.
What is the current status of trial NCT00701415?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2008-09. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00701415?
The interventions under investigation include: Agalsidase beta (BIOLOGICAL).
Who is sponsoring clinical trial NCT00701415?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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