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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
University Hepatitis Center at Bach & Godofsky MD PA
Sarasota, Florida, United States
Alamo Medical Research
San Antonio, Texas, United States
adverse events
laboratory evaluations
human anti-chimeric antibody
pharmacokinetic analysis
viral kinetic analysis
cytokine analysis
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