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NCT00464321 · ClinicalTrials.gov registry record · Phase 1
Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00464321 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 16 participants.
The verdict
NCT00464321, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The highest dose without excessive side effects will be investigated. Tests will determine how long GC1008 is in the body and how it is excreted.
Interventions
- BIOLOGICAL GC1008
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00464321
The ClinicalTrials.gov registry entry for NCT00464321 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 GC1008 is the first listed.
NCT00464321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00464321 about?
NCT00464321 is a clinical study titled "Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS". This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The highest dose without excessive side effects will be investigated. Tests will determine how long GC1008 is in the bod...
What is the current status of trial NCT00464321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-05. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00464321?
The interventions under investigation include: GC1008 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00464321?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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