Chronic hepatitis C
Conditions
Interventions
<
Sponsors
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 20 years old 2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml 3) Patients with previous history of pegylated interferon plus ribavirin therapy
Exclusion criteria
Exclusion criteria: 1) Patients with co-infection with hepatitis B virus 2) Patients with co-infection with human immunodeficiency virus 3) Patients with alcoholic liver disorder or autoimmune hepatitis 4) Patients with uncompensated cirrhosis or hepatic failure 5) Patients with multiple organ failure or immunological deficiency 6) Patients with severe depression or past history of psychiatric disorder 7) Patients with chronic renal failure 8) Patients in pregnancy or lactating or patients who expect to become pregnant 9) Patients whose hemoglobin levels are less than 12 g/dL 10) Patients whose platelet counts are less than 15,000 /microL 11) Patients whose neutrophil counts are less than 1,500 /microL 12) Patients whom investigator disqualified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Sustained virological response rate; the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| -Early virologic response; the rate of undetectable HCV RNA at 12 weeks of treatment -End of treatment virologic response rate; the rate of undetectable HCV RNA at end of treatment -The rate of patients without treatment discontinuation due to adverse event -The rate of adverse events -Drug adherence -Transition of quality of life | — |
Countries
Japan
Contacts
Public ContactNaoki Hiramatsu
Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed