PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Not Applicable
- Conditions
- Hepatitis C Virus
- Registration Number
- NCT00956982
- Lead Sponsor
- Kyushu University
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1251
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method antiviral effect by PEG-IFN alpha-2b plus RBV treatment 24-weeks follow-up after the end of treatment
- Secondary Outcome Measures
Name Time Method the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment during PEG-IFN alpha-2b plus RBV treatment (48 weeks)
Trial Locations
- Locations (1)
Department of General Medicine, Kyushu University Hospital
🇯🇵Fukuoka, Japan