Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503347
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2007-07-16
Brief Title:
Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
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 Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus
Status:
COMPLETED
Status Verified Date:
2011-06
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 trial is designed to assess the safety tolerability pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV
Detailed Description:
OBJECTIVES
To determine the safety and tolerability of bavituximab administered as multiple intravenous IV infusions to patients co-infected with HCV and HIV
To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV
To define the maximum tolerated dose MTD andor maximum effective dose MED of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV
To determine the safety and tolerability of bavituximab administered as multiple intravenous IV infusions to patients co-infected with HCV and HIV
To characterize the pharmacokinetic profile and viral kinetics after multiple intravenous infusions of bavituximab to patients infected with HCV and HIV
To define the maximum tolerated dose MTD andor maximum effective dose MED of bavituximab administered as multiple infusions to patients infected with chronic HCV infection and HIV
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