Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043706
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2002-08-12
Brief Title:
Safety Tolerability and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 12 Double Blind Placebo Controlled Randomized Dose Ranging Repeat Dose Study to Assess the Safety Tolerability and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 US and Europe to evaluate the safety tolerability and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None