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Effect of pegylated interferon and ribavirin therapy on the QOL in the treatment of chronic hepatitis C

Effect of pegylated interferon and ribavirin therapy on the QOL in the treatment of chronic hepatitis C - TOPIQS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003988
Enrollment
60
Registered
2010-08-10
Start date
2010-08-01
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

Pegintron/rebetol Pegintron/rebetol with celecoxib Pegasys/copegas Pegasys/copegas with celecoxib

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients infected with genotype 1 2. Patients with serum HCV-RNA level of 5 LogIU/mL or more. 3. Neutrophil count >= 1500/mm3 4. Platelet count >= 100000/mm3 5. Hemoglobin concentration >= 12 g/dl

Exclusion criteria

Exclusion criteria: 1. Patients who were previously treated with pegylated interferon and ribavirin therapy. 2. Patients who are pregnant or lactating. 3. Patients who cannot use birth control until 6 months pass after the end of treatment. 4. Patients who have hypersensitivity to interferons or ribavirin. 5. Patients who have uncontrolled heart diseases. 6. Patients with abnormal hemoglobin diseases. 7. Patients with chronic renal failure. 8. Patients with severe depression. 9. Patients with severe liver diseases. 10. Patients with autoimmune disorders. 11. Patients receiving other antiviral drugs, immunomodulating drugs, or Sho-Sai-Ko-To. 12. Patients who have hypersensitivity to aspirin or NSAID. 13. Patients who have peptic ulcers. 14. Patients who have asthma induced by aspirin or NSAID. 15. Patients who received antiviral therapy within 6 months. 16. Patients who have a history of interstitial pneumonia.

Design outcomes

Primary

MeasureTime frame
SF-36 score

Countries

Japan

Outcome results

None listed

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