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)

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) - Peginterferon alpha-2a/ribavirin plus meloxicam treatment for chronic hepatitis C (COMET study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001122

Enrollment

Registered

2008-04-19

Start date

2008-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis C

Interventions

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 w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) genotype 1 (2) TaqMan: 5 logIU/ml or greater (2) neutrophil counts; 1500/microL or greater (3) platelet counts; 90000/microL or greater (4) hemoglobin concentration; 12 g/dl or greater

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
rate of patients who require dose reduction	—

Secondary

Measure	Time frame
SVR virological response change in counts of neutrophil and platelet	—

Countries

Japan

Contacts

Public ContactTatehiro Kagawa

Tokai University School of Medicine Division of Gastroenterology, Department of Internal Medicine

kagawa@is.icc.u-tokai.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026