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