Trial Information

Chronic Hepatitis C- Non-Responsive to Prior Interferon Alfa Treatment

Title:T alpha 1-CHC-2K0804, A Multicenter Double-Blinded Study in Patients with Compensated Cirrhosis Due to Chronic Hepatitis C who are Non-Responders to Prior Interferon Alfa or Interferon Alfa + Ribavirin Therapy, Comparing Treatment with Thymosin Alpha 1 + Peg-Interferon Alfa-2a with Peg-Interferon Alfa-2a + Placebo

You may be eligible to participate in this research study if you:

Are over 18 years old
Have HCV (Hepatitis C) and cirrhosis (irreversible scarring of the liver)
Had at least 3 months of previous treatment with either IFN (Interferon) alone or IFN plus Ribavirin but were unresponsive
Have not taken IFN alone or IFN plus Ribavirin in the past 6 months
Have adequate renal (kidney) function

You are not eligible to participate in this research study if you:

Have been using any systemic corticosteroids or other drugs to treat your hepatitis C within the past 6 months
Have any injury to your liver as a result of drugs
Have any other liver disease besides hepatitis C
Have HIV infection or TB (tuberculosis)
Are pregnant
Take methadone often
Have a history of severe depression
Have seizures
Have had previous treatment with or known hypersensitivity to any of the study drugs listed in the Protocol Title above
Have received transplants
Have a significant pre-existing cardiac or pulmonary disease
Are participating in another clinical trial at this time, or if you participated in a study in the past 3 months

Stanley John, Research Coordinator
Biomedical Research Alliance of New York
VA Medical Center
423 East 23rd St
New York, NY 10010
Phone: 212-686-7500 x4477
Fax: 212-951-6356

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Research Center Information: Biomedical Research Alliance of New York

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