Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection

NCT00128271 | Completed Phase 1

• 1 other identifier: PPHM 0501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Keywords

HCV; monoclonal antibody; phase 1

Outcome Measures

Primary Outcomes (5)

• adverse events

• laboratory evaluations

• human anti-chimeric antibody

• pharmacokinetic analysis

• viral kinetic analysis

Interventions

Bavituximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (1)

Bach & Godofsky, MD, PA

Bradenton, Florida, 34205, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

bavituximab

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Eliot W Godofsky, MD, FACP

  Bach & Godofsky, MD, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 9, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2006
• Last Updated: May 7, 2008

Record last verified: 2006-08

Locations

US (1)