NCT00343525

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

April 1, 2008

Enrollment Period

8 months

First QC Date

June 21, 2006

Last Update Submit

April 28, 2008

Conditions

Hepatitis C

Keywords

HCVmonoclonal antibodyphase 1

Outcome Measures

Primary Outcomes (6)

  • adverse events

  • laboratory evaluations

  • human anti-chimeric antibody

  • pharmacokinetic analysis

  • viral kinetic analysis

  • cytokine analysis

Interventions

bavituximabDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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)

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, 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hepatitis Center at Bach & Godofsky MD PA

Sarasota, Florida, 34243, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

bavituximab

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Eric Lawitz, MD

    Alamo Medical Research

    PRINCIPAL INVESTIGATOR

  • Eliot W Godofsky, MD

    University Hepatitis Center

    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

June 21, 2006

First Posted

June 23, 2006

Study Start

May 1, 2006

Primary Completion

January 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-04

Locations

US(2)