Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343525
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2006-06-21
Brief Title:
Repeat-Dose Study of Bavituximab in Patients With Chronic Hepatitis C
Sponsor:
Peregrine Pharmaceuticals
Organization:
Peregrine Pharmaceuticals
Study Overview
Official Title:
A Phase Ib Open-Label Escalating Repeat-Dose Trial of Bavituximab Chimeric Anti-Phosphatidylserine Monoclonal Antibody in Patients With Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2008-04
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:
The purpose of this study is to determine the safety and tolerability of bavituximab when administered via an arm vein as multiple infusions and to examine how bavituximab behaves in the body and how it effects the amount of hepatitis C virus and immune modulators in individuals with chronic infection
Detailed Description:
Hepatitis C virus HCV infection is a world wide public health concern and is the most common chronic bloodborne infection in the United States and the leading indication for liver transplantation Laboratory and animal studies have demonstrated that bavituximab binds viruses and virally infected cells and prolongs survival in lethally infected animals This study will examine the safety and tolerability of bavituximab when administered as multiple infusions to patients with chronic HCV infection Groups of patients will be treated with escalating doses of bavituximab twice weekly for 2 weeks and followed for 12 weeks
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