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Phase I Study New Hep C Drug for Peg/RBV Nonresponders
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Phase I Study New Hep C Drug for Peg/RBV Nonresponders

Anyone interested in joining a study for the evaluation of a new drug....pls read details below:
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Phase I Study New Hep C Drug for Peg/RBV Nonresponders

Peregrine Pharmaceuticals' anti-viral Phase 1 trial is designed to evaluate the safety of escalating doses of Tarvacin in patients with chronic Hepatitis C virus infection.

Below is a summary of the trial parameters:

Tarvacin is a monoclonal antibody designed for solid-tumor cancers.
http://www.tarvacin.com

Protocol Title:
A Phase I 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

Contact Information
Karen Roberts, MS      714.508.6035    ***@****

PHASE I STUDY SITE  
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

Phase: I
Indications: Chronic Hepatitis C virus (HCV) Infection

Objectives:
--Determine safety and tolerability
--Characterize blood pharmacokinetics and viral kinetics
--Define the maximum tolerated dose (MTD) and/or maximum effective dose (MED)

Selected Eligibility Criteria:
    
Inclusion
--Must be 18 years of age
--Chronic HCV infection based on medical history and detectable serum HCV RNA

--Failure to respond to or relapse after treatment with pegylated interferon plus ribavirin

Exclusion
--No prior exposure to any chimeric antibody
--No decompensated clinical liver disease or cirrhosis or other cause of liver disease such as alcoholic liver disease
--No uncontrolled intercurrent disease
--No requirement for chronic daily treatment with NSAIDs, anti-platelet drugs or steroids
--Must not be pregnant or nursing
--No prior thrombotic or hemorrhagic disorders



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NATAP nataphcv mailing list -- ***@****

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thanks for the details, Ben. Someone gave us a preview on an 8/8 thread, I wonder if they got their 30 subjects by now? I think it was mentioned that they were looking for 30 individuals, or did I imagine that one?
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Get tested for hepatitis C



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is that the LOLA article?
Cin
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Affirmative!
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Thanks!
Cin
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You very welcome...
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