Chronic hepatitis C
Conditions
Interventions
Darbepoetin alpha in combination with peginterferon alpha-2b plus ribavirin.
Peginterferon alpha-2b plus ribavirin.
Sponsors
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Chronic hepatitis C with HCV genotype 1 and high viral load (HCV RNA >= 5 Log IU/mL). 2. 50 years-old or older and youger than 70 years-old. 3. Women. 4. Hemoglobin concentration >= 12 g/dL and < 15 g/dL. 5. White blood cell count >=4,000/mm3. 6. Neutrophil count >=1,500/mm3. 7. Platelet count >=10,000/mm3.
Exclusion criteria
Exclusion criteria: 1. Allergic to peginterferon alpha-2b or other interferon preparations. 2. Allergic to vaccine or biological preparations. 3. Allergic to ribavirin or other nucleoside analogue 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. Severe depression or psychiatric disorders including a history of a suicide attempt. 9. Severe or decompensated liver disease. 10. Vascular diseases of central nervous system. 11. Autoimmune liver diseases. 12. Concomitant herbal medication such as Sho-saiko-to. 13. Allergic to darbepoetin alpha or other erythropoietin preparations. 14. Other conditions considered inappropriate by attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rates of negative result of qualitative HCV RNA test at 12 weeks of treatment, end of treatment, and 24 weeks after terminating therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The incidence rates of dose reduction and discontinuation of ribavirin. 2) Changes in hemoglobin concentration. 3) The incidence rates of completion of the combination therapy of peginterferon alpha-2b plus ribavirin. 4) Assessment of the QOL by SF-36 ver. 2 at baseline and at 4 and 24 weeks of treatment. 5) Adverse events and their incidence rates and grade. | — |
Countries
Japan
Contacts
Public ContactYoshiaki Iwasaki
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Gastroenterology and Hepatology
Outcome results
None listed