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

UMIN ID: UMIN000015230

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: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Standard starting dose of peginterferon alpha-2b (pegintron) in combination with lower starting dose of ribavirin (Rebetol) by 200 mg, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8.
Lower stating dose of peginterferon alpha-2b (pegintron) in combination with lower starting dose of ribavirin (Rebetol) by 200 mg, 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 according 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 thereafter 3. Incidence of dose modification and discontinuation of therapy

Key inclusion & exclusion criteria

• Age minimum: 60years-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