chronic hepatitis C patients with genotype 1 and high viral loads
Conditions
Interventions
None listed
Sponsors
Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients with a positive HCV-RNA in the serum (more than or equal to 5.0 log IU/mL) 2. patients with genotype 1a or 1b 3. patients who gave consent in writing
Exclusion criteria
Exclusion criteria: 1. chronic hepatitis such as autoimmune hepatitis and alcoholic hepatitis 2. pregnant women, women who may be expecting a child or lactating woman 3. women of child-bearing potential and their partner who cannot use birth control during administration and for 6 months after completion of administration 4. male partner for a pregnant woman, who cannot use birth control during administration and for 6 months after completion of administration 5. patients with past history of hypersensitivity to IFN or bovine-derived material 6. patients with past history of hypersensitivity to ribavirin and other nucleoside analog 7. patients with past history of hypersensitivity to biological products such as vaccine 8. patients with uncontrolled diabetes mellitus 9. patients with uncontrolled heart disease 10. patients with hemoglobinopathy 11. chronic renal failure or severe renal dysfunction with less than 50 mL/min Ccr 12. patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases 13. patients with severe liver dysfunction 14. patients with interstitial pneumonitis 15. patients with past history of drug hypersensitivity or tendency to develop allergy 16. patients receiving Shosaikoto 17. patients judged as inappropriate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| virological response | — |
Countries
Japan
Contacts
Public ContactKen Sato
Gunma University Graduate School of Medicine Department of Medicine and Molecular Science
Outcome results
None listed