Repeat-Dose Study of Bavituximab in Patients With Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343525
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : May 7, 2008
Information provided by:
Peregrine Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: bavituximab Phase 1

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients With Chronic Hepatitis C
Study Start Date : May 2006
Actual Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. adverse events
  2. laboratory evaluations
  3. human anti-chimeric antibody
  4. pharmacokinetic analysis
  5. viral kinetic analysis
  6. cytokine analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 years of age
  • Chronic Hepatitis C infection based on history and detectable serum HCV RNA including treatment naïve subjects as well as subjects who are partial responders and/or relapsers to prior therapy(ies)
  • All genotypes of HCV acceptable
  • Complete Blood Counts within normal limits
  • Normal renal function (serum creatinine within normal limits)
  • Normal coagulation profile (PT/INR and aPTT within normal limits)
  • Patients of reproductive potential must agree to use an approved form of barrier contraception. Female patients must have a negative serum pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)

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, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
  • Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
  • Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
  • Any history of thromboembolic events [e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)] including central venous catheter-related thrombosis within the past 12 months
  • Concurrent therapy with oral or parenteral anticoagulants
  • Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
  • Antiviral therapy within 4 weeks of day 0
  • Investigational therapy within 4 weeks of day 0
  • Major surgery within 4 weeks of day 0
  • Pregnant or nursing women
  • Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid 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 (including wound healing by secondary intention, ulcer, or bone fracture)
  • Requirement for chronic daily treatment with NSAIDs, antiplatelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
  • Cancer, autoimmune disease or any disease or concurrent therapy known to cause significant alteration in immunologic function
  • Known chronic infection with HIV or HBV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343525

United States, Florida
University Hepatitis Center at Bach & Godofsky MD PA
Sarasota, Florida, United States, 34243
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Peregrine Pharmaceuticals
Principal Investigator: Eric Lawitz, MD Alamo Medical Research
Principal Investigator: Eliot W Godofsky, MD University Hepatitis Center

Responsible Party: Dianne Uphoff/Senior Clinical Project Manager, Peregrine Pharmaceuticals Identifier: NCT00343525     History of Changes
Other Study ID Numbers: PPHM 0601
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 2008

Keywords provided by Peregrine Pharmaceuticals:
monoclonal antibody
phase 1

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs