Efficacy of pegylated interferon plus ribavirin lead-in therapy on telaprevir with pegylated interferon plus ribavirin therapy for aged patients with chronic hepatitis C genotype 1
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000007329
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 410
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response rate; the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment
- Secondary Outcome Measures
Name Time Method 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