Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection

Inclusion Criteria: * At least 18 years of age * Chronic hepatitis C infection based on history and detectable serum HCV RNA * Documented failure to respond to or relapse after treatment with pegylated interferon and ribavirin combination therapy * Adequate hematologic function (absolute neutrophil count \[ANC\] greater than or equal to 1,500 cells/uL, hemoglobin \[Hgb\] greater than or equal to 12 g/dL in females and greater than or equal to 13 g/dL in males, platelet count greater than or equal to 100,000/uL and less than or equal to 500,000/uL) * Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min) * Normal coagulation profile (PT/INR and aPTT within institutional normal limits) * D-dimer within institutional limits * Female patients of childbearing potential must have a negative serum pregnancy test at prestudy and all patients of reproductive potential must be willing to use an approved form of barrier method contraception Exclusion Criteria: * Prior exposure to any chimeric antibody * Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease * Decompensated clinical liver disease or cirrhosis * Any evidence of clinically significant bleeding * Known history of bleeding diathesis or coagulopathy * Any history of thromboembolic events including central venous catheter-related thrombosis * Any evidence or history of a hypercoagulable state (eg, elevated d-dimer or shortened aPTT) * Concurrent therapy with oral or parenteral anticoagulants * Concurrent hormone therapy (ie, estrogen contraceptives, hormone replacement, anti-estrogen) * Antiviral therapy within 90 days of day 0 * Investigational therapy within 4 weeks of day 0 * Major surgery within 4 weeks of day 0 * Uncontrolled intercurrent disease * Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack * A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin * A history of any condition requiring treatment (past or current) with coumarin-type agents * Cardiac arrhythmia requiring medical therapy * Serious non-healing wound * Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids * A disease or concurrent therapy known to cause significant alteration in immunologic function * Known HIV or active hepatitis B virus (HBV) infection