Chronic hepatitis C
Conditions
Interventions
The group of patients treated with pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy The patients with HCV RNA decrease more than 3
less than 60 Kg, 600 mg/day p.o., more than 60 Kg and less than 80 kg, 800 mg/day p.o., more than 80 kg, 1000 mg/day, p.o. Treatment duration: 48 weeks or 72 weeks according to response-guided therap
less than 60 Kg, 600 mg/day p.o., more than 60 Kg and less than 80 kg, 800 mg/day p.o., more than 80 kg, 1000 mg/day, p.o. Telaprevir: 1500 mg/day p.p. Treatment duration: Pegylated interferon and R
24 weeks, Telaprevir
12 weeks
The group of patients treated with pegylated interferon plus ribavirin therapy Pegylated interferon alpha 2b: 1.5 mcg/kg/w i.s. Ribavirin: Body weight
Sponsors
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 65 years old 2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml 3) Patients without previous history of pegylated interferon plus ribavirin therapy
Exclusion criteria
Exclusion criteria: 1) Patients with co-infection with hepatitis B virus and positive of HBs antigen 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 or less than 50 ml/min of creatinine clearance 8) Patients whose hemoglobin levels are less than 12 g/dL 9) Patients whose platelet counts are less than 15,000 /microL 10) Patients whose neutrophil counts are less than 1,500 /microL 11) 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 |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoki Hiramatsu
Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed