Chronic hepatitis C
Conditions
Interventions
Combination therapy of peginterferon alpha-2a plus ribavirin.
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with HCV serogroup 1 (Genotype 1a or 1b) and high viral load (HCV RNA >= 100 KIU/mL) or non-responders or relapsers to the previous standard interferon monotherapy.
Exclusion criteria
Exclusion criteria: 1. Pregnant or under breast feeding. 2. Allergic to ribavirin or other nucleoside preparations. 3. Uncontrolled cardiovascular diseases. 4. Abnormal hemoglobinemia. 5. Chronic renal failure or creatinine clearance value less than 50 mL/min. 6. Depression or psychiatric disorders. 7. Sever or decompensated liver disease. 8. Autoimmune liver diseases. 9. White blood cell count <3,000/microL, neutrophil count <1,500/microL, platelet count <90,000/microL, or hemoglobin concentration <12 g/dL. 10. Allergic to pegylated interferon alpha-2a or other interferon preparations. 11. Allergic to vaccine or biological preparations. 12. Concomitant herbal medication such as Sho-saiko-to. 13. Other conditions considered inappropriate by attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy. 2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration). 3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy. 4. HCV Core and NS5A ISDR amino acid replacement and virological response. | — |
Countries
Japan
Contacts
Public ContactYoshiaki Iwasaki
Okayama University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed