Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

Launched by KAOHSIUNG MEDICAL UNIVERSITY CHUNG-HO MEMORIAL HOSPITAL · Sep 4, 2013

Keywords

ClinConnect Summary

The aims of the present study are:

1. To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment)
2. To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus standard-dose of RBV in HCV virus genotype 1 infected, tr...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Male and female patients \*18 years of age
• • Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
• • Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
• • Detectable serum HCV-RNA and HCV viral genotype 1
• • Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
• • Compensated liver disease (Child-Pugh Grade A clinical classification)
• • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
• • All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
• Exclusion Criteria:
• • Women with ongoing pregnancy or breast feeding
• • Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \*6 months prior to the first dose of study drug
• • Any investigational drug \*6 weeks prior to the first dose of study drug
• • Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
• • History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• • Signs or symptoms of hepatocellular carcinoma
• • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• • Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening