PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

Kyushu University

Status

Unknown

Conditions

Hepatitis C Virus

Treatments

Drug: Pegylated interferon alpha-2b plus ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00956982

KULDS2009

Details and patient eligibility

About

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).

Enrollment

1,251 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.