Chronic hepatitis type C
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients whose HCV-serotype 1 or 2 2) age, over 20 years old and under 75 years old 3) male and female 4) Patients who don't diagnosed cirrhosis by imaging findings or blood exsamination. 5) Patients who has no HCC by imaging findings.
Exclusion criteria
Exclusion criteria: 1) Patient whose serum HCV RNA level under 5.0 log IU/ml and who taken initial therapy. 2) Patients with sensitivities for peg-interferon alpha 2b or other interferons. 3) Patients with sensitivities for vaccine. 4) Patients with sensitivities for ribavirin or other nucleic acid analogs. 5) a pregnant woman, or woman who may pregnant and who are nursing. 6) PAtients who had bad controled heart disease. 7) Patients who had hemoglobinemia. 8) Patients who had Chronic renal failure or whose creatinine clearance under 50ml/min. 9) Patients who had depression. 10) Patients who had severe liver disfunction or bile duct obstruction. 11) Patients who had cerebral hemorrhage or cerebral infarction. 12) PAtients who medicated by shousaikoto. 13) Patients who had autoimmune hepatitis. 14) Patients who had chronic hepatitis type B, alcoholic liver injury. 15) Patients who were disqualified by doctor in attendance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of nagative HCV RNA at 24 weeks after the initiation of treatment (The SVR rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of negative HCV RNA (at 4 weeks, 12 weeks of combination therapy and end of the initiation therapy) 2) Change in hemoglobin 3) Dose of drug (peginterferon dose, ribavirin dose) 4) Change in insulin resistance 5) Occurrence of side effect | — |
Countries
Japan
Contacts
Yamaguchi Univercity Graduate School of Medicine Department of Gastroenterology and Hepatology