Trial | NCT00956982  Report issue

Title

PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    1251
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).
Study Started
Dec 31
2004
Primary Completion
Jul 31
2008
Study Completion
Dec 31
2012
Anticipated
Last Update
Aug 11
2009
Estimate

Drug Pegylated interferon alpha-2b plus ribavirin

All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively

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.
No Results Posted