Open-label, randomized, controlled study peginterferon alpa-2b plus dose-escalation of ribavirin in patients with chronic hepatitis C

UMIN ID: UMIN000015229

Registered date:01/10/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C
• Date of first enrollment: 2006/01/01
• Target sample size: 380
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Standard therapy of 48 weeks according to package insert of peginterferon alpha 2b plus ribavirin
Starting with lower dose of ribavirin than standard dose according to package insert by 200 mg in combination with peginterferon alpha-2b, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8

Outcome(s)

• Primary Outcome: Rate of negative results of qualitative HCV RNA test (end-of-treatment and 24 weeks after terminating therapy
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Okayama University Hospital
• Source(s) of Monetary Support: Not applicable