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NCT00146770 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT00146770 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 45 participants.
The verdict
NCT00146770, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL Aldurazyme
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2001-05 |
| Est. Completion | 2005-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00146770
The ClinicalTrials.gov registry entry for NCT00146770 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 45 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 2 interventions - of which placebo is the first listed.
NCT00146770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00146770 about?
NCT00146770 is a clinical study titled "Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients". This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.
What is the current status of trial NCT00146770?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2001-05. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00146770?
The interventions under investigation include: placebo (BIOLOGICAL), Aldurazyme (BIOLOGICAL).
Who is sponsoring clinical trial NCT00146770?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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