Status:
UNKNOWN
PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Lead Sponsor:
Kyushu University
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18+ years
Phase:
NA
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) infe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
1251 Patients enrolled
Trial Details
Trial ID
NCT00956982
Start Date
December 1 2004
End Date
December 1 2012
Last Update
August 11 2009
Active Locations (1)
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1
Department of General Medicine, Kyushu University Hospital
Fukuoka, Japan, 812-8582