Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bavituximab

Criteria

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