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NCT00365131 · ClinicalTrials.gov registry record · Phase 4

A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.

A Phase 4 study, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target

NCT00365131: Completed Phase 4 study, sponsored by Genzyme, a Sanofi Company.

NCT00365131 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00365131, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target

Study Summary

This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating patients with skeletal manifestations secondary to Type I Gaucher disease. The study objective is to evaluate and quantify skeletal responses as compared to baseline in Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional objectives were to assess the usefulness of various skeletal parameters, such as bone pain, bone crises, bone mineral density, and serum and urine bone markers, as indicative of treatment response and may be useful in dose management.

Interventions

  • DRUG Cerezyme (imiglucerase for injection)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 1997-12
Est. Completion 2004-07
Phase Phase 4
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00365131 record still lists

NCT00365131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Cerezyme (imiglucerase for injection) is the first listed.

NCT00365131 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00365131 about?

NCT00365131 is a clinical study titled "A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.". This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating patients with skeletal manifestations secondary to Type I Gaucher disease. The study objective is to evaluate and quantify skeletal responses as compared to baseline in Type I gaucher disease patients recei...

What is the current status of trial NCT00365131?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 1997-12. Estimated completion is 2004-07.

What interventions are being tested in trial NCT00365131?

The interventions under investigation include: Cerezyme (imiglucerase for injection) (DRUG).

Who is sponsoring clinical trial NCT00365131?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00365131's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00365131, the US trial registry maintained by the National Library of Medicine. NCT00365131 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.