A Phase 1 Study of Tarvacin in Patients with Chronic Hepatitis C
Virus Infection

This study is currently recruiting patients.
Verified by Peregrine Pharmaceuticals August 2005

Sponsored by: Peregrine Pharmaceuticals
Information provided by: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00128271


Purpose

The purpose of this study is to determine the safety and
tolerability of Tarvacin when administered via a vein as a single
infusion and to examine how Tarvacin behaves in the body and how it
effects the amount of hepatitis C virus in individuals with chronic
infection.
Condition Intervention Phase
Hepatitis C
Drug: Tarvacin
Phase I


MedlinePlus related topics: Hepatitis C


Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled,
Single Group Assignment, Safety Study

Official Title: A Phase 1 Study of Chimeric Anti-Phosphatidylserine
Monoclonal Antibody (Tarvacin) in Patients Chronically Infected with
Hepatitis C Virus (HCV) Who Are Non-Responders or Relapsers After
Treatment with Pegylated Interferon Plus Ribavirin

Further Study Details:
Primary Outcomes: adverse events; laboratory evaluations; human anti-
chimeric antibody; pharmacokinetic analysis; viral kinetic analysis
Expected Total Enrollment: 32
Study start: August 2005


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 Tarvacin binds
viruses and virally infected cells and prolongs survival in infected
animals. This study will examine the safety and tolerability of
Tarvacin 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.
Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for
Study: Both
Criteria
Inclusion Criteria:

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 (ANC greater than or equal to 1,500
cells/uL, 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
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 or cirrhosis
Any evidence of clinically significant bleeding
Known histroy 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
A history of any condition requiring treatment (past or current)
with coumarin-type agents
Cardiac arrhythmia requiring medical therapy
Serious non-healing wound
Requirement for chronic daily treatment with NSAIDs, anti-platelet
drugs (eg, phosphodiesterase inhibitors, adenosine diphophate
receptor antagonists), or steriods
A disease or concurrent therapy know to cause significant alteration
in immunologic function
Known HIV or active HBV infection
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier
NCT00128271

Karen Roberts, MS 714.508.6035 kroberts@...


Florida
Bach & Godofsky, MD, PA, Bradenton, Florida, 34205, United
States; Recruiting
Mickey Mays, RNMS, ARNP 941-746-2711 Ext. 39
Eliot W Godofsky, MD, Principal Investigator

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