PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyushu University
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.

• All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.

Exclusion Criteria:

• Clinical or biochemical evidence of hepatic decompensation.

• Advanced cirrhosis identified by large esophageal varices (F2 or F3).

• History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.

• Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.

• Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).

• Excessive active alcohol consumption > 60 g/day or drug abuse.

• Severe psychiatric disease.

• Antiviral or corticosteroid therapy within 12 months prior to the enrollment.