An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.

UMIN ID: UMIN000001033

Registered date:29/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis C with serogroup 1 and high viral load (>= 100 KIU/mL).
• Date of first enrollment: 2007/09/01
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Starting with a standard dose of ribavirin in combination with peginterferon alpha-2a, followed by ribavirin reduction by 200 mg/day upon a decline of hemoglobin concentration by 2 g/dL or more from baseline at week 2 of therapy.
Starting with a ribavirin dose according to the ribavirin apparent clearance in combination with peginterferon alpha-2a, followed by stepwise dose-escalation by 100 mg/day in cases starting with a lower dose of ribavirin and hemoglobin concentration at or above 12 g/dL at week 4 and 8 of therapy.

Outcome(s)

• Primary Outcome: Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy.
• Secondary Outcome: 1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy. 2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration). 3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy. 4. Assessment of quality of life. 5. HCV Core and NS5A ISDR amino acid replacement and virological response.

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 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.

Related Information

• Primary Sponsor: Okayama University Hospital
• Source(s) of Monetary Support: None