Trial Information

Summary: Patients with cirrhosis due to chronic hepatitis C who are 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

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Trial listings updated: June 1, 2008 at 5:43:27 AM