Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125385
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2005-07-29
Brief Title:
Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis IPF
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase I Open-Label Multi-Center Single-Dose Dose-Escalating Safety Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to investigate whether GC1008 an antibody that neutralizes TGFb is safe in treating patients with idiopathic pulmonary fibrosis The highest dose without excessive side effects will be identified Tests will determine how long GC1008 is in the body and how it is excreted
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