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NCT00081497 · ClinicalTrials.gov registry record · Phase 4
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 67
- Enrollment target
NCT00081497: Completed Phase 4 study, sponsored by Genzyme, a Sanofi Company.
NCT00081497 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 67 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081497, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 67 participants
- Enrollment target
Study Summary
People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study analyzed the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that previously participated in the AGAL-008-00 (NCT0074984) study.
Primary Outcome
The primary efficacy analysis was the summary of change in slope of inverse serum creatinine for Placebo/Fabrazyme patients in the Intent to Treat (ITT) Population. It compared the placebo period slope with the Fabrazyme period slope.
Interventions
- BIOLOGICAL agalsidase beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
What the finished NCT00081497 record still lists
NCT00081497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which agalsidase beta is the first listed.
NCT00081497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00081497 about?
NCT00081497 is a clinical study titled "A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease". People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". These glycolipids are normall...
What is the current status of trial NCT00081497?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 67 participants. The study started on 2004-01. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00081497?
The interventions under investigation include: agalsidase beta (BIOLOGICAL).
Who is sponsoring clinical trial NCT00081497?
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 NCT00081497's enrollment target sits among peer trials
67 1083rd of 2000 higher than 918 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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