NCT00128271

Study of Bavituximab in Patients With Chronic Hepatitis C Virus Infection

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Bavituximab

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-08-01
• First posted: 2005-08-09
• Last updated: 2008-05-07

Locations

1 site across 1 country: United States