A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis C

UMIN ID: C000000402

Registered date:17/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: serotype 2 chronic hepatitis C
• Date of first enrollment: 2006/04/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

PEG-IFN alpha-2b (1.5ug/kg) + reduced dose ribavirin (400-800 mg)
PEG-IFN alpha-2b (1.5ug/kg) + standard dose ribavirin (600-1,000mg)

Outcome(s)

• Primary Outcome: sustained viral response (negative HCV-RNA 24 weeks after the end of treatment)
• Secondary Outcome: (1) percentage of patients in whom drug dose is reduced or treatment is discontinued (2) change in Hgb levels

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) pregnant women (2) patients allergic to ribavirin or IFN (3) patients with uncontrolled heart diseases (4) patients with abnormal hemoglobin (5) patients with chronic renal diseases (6) patients with severe depression or mental illness (7) patinets with liver cirrhosis or liver failure (8) patients who can not discontinue other antiviral or immunomodulating drugs

Related Information

• Primary Sponsor: Tokai University School of Medicine
• Source(s) of Monetary Support: Tokai University School of Medicine, Department of Gastroenterology