An open-label, randomized, controlled study of peginterferon alpha-2a/ribavirin plus meloxicam treatment for the patients with genotype 1 chronic hepatitis C (COMET study)

UMIN ID: UMIN000001122

Registered date:19/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: chronic hepatitis C
• Date of first enrollment: 2008/03/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

PEG-IFN alfa-2a 180 microgram weekly plus ribavirin (600-1000 mg/day) for 48 weeks
PEG-IFN alfa-2a 180 microgram weekly plus ribavirin (600-1000 mg/day) for 48 weeks plus meloxicam (10 mg/day) for 8 weeks

Outcome(s)

• Primary Outcome: rate of patients who require dose reduction
• Secondary Outcome: SVR virological response change in counts of neutrophil and platelet

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: None