Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection
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The purpose of this study is to determine the safety and tolerability of bavituximab when administered via a vein as a single infusion and to examine how bavituximab behaves in the body and how it affects the amount of hepatitis C virus in individuals with chronic infection.
Condition or disease
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 infected animals. This study will examine the safety and tolerability of bavituximab when administered to patients with chronic HCV infection who do not respond to or relapse after treatment with pegylated interferon plus ribavirin combination therapy. Groups of patients will be treated with escalating doses and followed for 12 weeks.
A Phase 1 Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody (Bavituximab) in Patients Chronically Infected With Hepatitis C Virus (HCV) Who Are Non-Responders or Relapsers After Treatment With Pegylated Interferon Plus Ribavirin
Study Start Date
Actual Primary Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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