An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.
- Conditions
- Chronic hepatitis C with serogroup 1 and high viral load (>= 100 KIU/mL).
- Registration Number
- JPRN-UMIN000001033
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 240
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method