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NCT00912925 · ClinicalTrials.gov registry record · Phase 3
Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT00912925: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00912925 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00912925, 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 demonstrate the safety and clinical efficacy of Aldurazyme treatment in MPS I patients
Primary Outcome
Percent Predicted Forced Vital Capacity (FVC): the maximal exhaled breathe volume following a maximal inhaled breath. Overall Change from Baseline to Week 26 in percent predicted FVC = (observed value)/(predicted value) \* 100%). A higher value indicates a greater response.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL rhIDU (recombinant human-Alpha-L-Iduronidase)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2000-12 |
| Est. Completion | 2001-09 |
| Phase | Phase 3 |
What the finished NCT00912925 record still lists
NCT00912925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00912925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00912925 about?
NCT00912925 is a clinical study titled "Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) I". This study is being conducted to demonstrate the safety and clinical efficacy of Aldurazyme treatment in MPS I patients
What is the current status of trial NCT00912925?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2000-12. Estimated completion is 2001-09.
What interventions are being tested in trial NCT00912925?
The interventions under investigation include: Placebo (BIOLOGICAL), rhIDU (recombinant human-Alpha-L-Iduronidase) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00912925?
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 NCT00912925's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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