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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 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 67 participants.
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.
Interventions
- BIOLOGICAL agalsidase beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081497
The ClinicalTrials.gov registry entry for NCT00081497 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 67 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.
NCT00081497 reports 0 study locations.
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.
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