NCT00343525

Repeat-Dose Study of Bavituximab in Patients With Chronic Hepatitis C

A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients With Chronic Hepatitis C

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	bavituximab

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-01-01
• First posted: 2006-06-23
• Last updated: 2008-05-07

Locations

2 sites across 1 country: United States