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NCT00074984 · ClinicalTrials.gov registry record · Phase 4
A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT00074984 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 82 participants.
The verdict
NCT00074984, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to breakdown and remove 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 ("globotriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Fabrazyme (agalsidase beta)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2001-02 |
| Est. Completion | 2004-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00074984
The ClinicalTrials.gov registry entry for NCT00074984 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 82 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.
NCT00074984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00074984 about?
NCT00074984 is a clinical study titled "A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease". People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally pres...
What is the current status of trial NCT00074984?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2001-02. Estimated completion is 2004-01.
What interventions are being tested in trial NCT00074984?
The interventions under investigation include: Placebo (BIOLOGICAL), Fabrazyme (agalsidase beta) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00074984?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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