serotype 2 chronic hepatitis C
Conditions
Interventions
PEG-IFN alpha-2b (1.5ug/kg) + reduced dose ribavirin (400-800 mg)
PEG-IFN alpha-2b (1.5ug/kg) + standard dose ribavirin (600-1,000mg)
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) genotype 2 chronic hepatitis C (2) patients with viral loads of 100 KIU/mL or more, or patients who did not respond to IFN monotherapy (3) patients satisfying below criteria within 30 days before entry (3-1) leukocyte count with 4000/mm3 or greater (3-2) neutrophil count with 1500/mm3 or greater (3-3) platelet count with 100000/mm3 or greater (3-4) hemoglobin level with 12.0 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 |
|---|---|
| sustained viral response (negative HCV-RNA 24 weeks after the end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) percentage of patients in whom drug dose is reduced or treatment is discontinued (2) change in Hgb levels | — |
Countries
Japan
Contacts
Public ContactKagawa, Tatehiro
Tokai University School of Medicine Gastroenterology
Outcome results
None listed