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

This study has been completed.
Sponsor:
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00343525
First received: June 21, 2006
Last updated: April 28, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Hepatitis C
Drug: bavituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • adverse events
  • laboratory evaluations
  • human anti-chimeric antibody
  • pharmacokinetic analysis
  • viral kinetic analysis
  • cytokine analysis

Enrollment: 24
Study Start Date: May 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343525

Locations
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
Investigators
Principal Investigator: Eric Lawitz, MD Alamo Medical Research
Principal Investigator: Eliot W Godofsky, MD University Hepatitis Center
  More Information

No publications provided

Responsible Party: Dianne Uphoff/Senior Clinical Project Manager, Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00343525     History of Changes
Other Study ID Numbers: PPHM 0601
Study First Received: June 21, 2006
Last Updated: April 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:
HCV
monoclonal antibody
phase 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014