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Phase I Study New Hep C Drug for Peg/RBV Nonresponders
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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 kroberts@peregrineinc.com
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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