Chronic hepatitis C
Conditions
Interventions
Standard therapy of 48 weeks according to package insert of peginterferon alpha 2b plus ribavirin
Starting with lower dose of ribavirin than standard dose according to package insert by 200 mg in comb
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HCV genotype 1 an HCV RNA level 100,000 IU/mL or more 2. Cirrhosis has been excluded by histological data, image diagnosis, and laboratory tests 3. Without omplication with hepatocellular carcinoma
Exclusion criteria
Exclusion criteria: 1. Hemoglobin values at entry visit less than 12 g/dL 2. Allergic to interferon or vaccine preparations 3. Allergic to ribavirin or other nucleos(t)ide preparations 4. Pregnant or under breast feeding 5. Uncontrolled cardiovascular diseases 6. Abnormal hemoglobinemia 7. Chronic renal failure or creatinine clearance value less than 50 mL/min 8. Neurologic or psychiatric disease 9. Sever or decompensated liver disease 10. Hypertension or diabetes 11. History of apoplexy 12. Autoimmune hepatitis 13. Chronic hepatitis B or excessive daily intake of alcohol 14. Concomitant immunosuppressive or herbal medication such as Sho-saiko-to 15. Other conditions considered inappropriate by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of negative results of qualitative HCV RNA test (end-of-treatment and 24 weeks after terminating therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sustained virological response rate accordong to the time point of viral disappearance 2. Rate of anemia (defined as hemoglobin concentration < 10 g/dL) at every week up to week 8 and every 4 weeks therafter 3. Incidence of dose modification and discontinuation of therapy | — |
Countries
Japan
Contacts
Public ContactYoshiaki Iwasaki
Okayama University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed