An open-label, randomized, controlled trial to assess the efficacy and safety of teprenone in chronic hepatitis C patients concurrent with chronic gastritis treated with peginterferon alpha-2b plus ribavirin.
- Conditions
- Chronic hepatitis C patients with genotype 1 and high viral load (>= 5 Log IU/mL) concurrent with chronic gastritis.
- Registration Number
- JPRN-UMIN000001391
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
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 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. Sever or decompensated liver disease or obstruction of biliary tract. 10. Vascular diseases of central nervous system. 11. Concomitant herbal medication such as Sho-saiko-to. 12. Autoimmune liver diseases. 13. Chronic liver diseases other than hepatitis C virus such as hepatitis B virus and excessive alcohol intake. 14. 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