Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribaviri
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000004141
- Lead Sponsor
- Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 21
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.