Open-label, randomized, controlled study peginterferon alpa-2b plus dose-escalation of ribavirin in patients with chronic hepatitis C
Not Applicable
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000015229
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of negative results of qualitative HCV RNA test (end-of-treatment and 24 weeks after terminating therapy
- Secondary Outcome Measures
Name Time Method 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