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NCT00043706 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00043706 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company.
The verdict
NCT00043706, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis eventually causes the involved skin to harden, limiting mobility, and can also damage other organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is currently investigating a human monoclonal antibody (CAT-192) that neutralizes active TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety, tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis.
Interventions
- DRUG Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
Trial Details
| Field | Value |
|---|---|
| Est. Completion | 2003-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00043706
The ClinicalTrials.gov registry entry for NCT00043706 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. 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 Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody is the first listed.
NCT00043706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00043706 about?
NCT00043706 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis". Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis eventually causes the involved s...
What is the current status of trial NCT00043706?
This trial is currently completed. It is a Phase 1 study. Estimated completion is 2003-09.
What interventions are being tested in trial NCT00043706?
The interventions under investigation include: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody (DRUG).
Who is sponsoring clinical trial NCT00043706?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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