Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin in patients with chronic hepatitis C
Not Applicable
- Conditions
- Patients with chronic hepatitis C virus infection
- Registration Number
- JPRN-UMIN000012183
- Lead Sponsor
- Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
1) Co-infection with hepatitis B virus 2) Co-infection with anti-human immunodeficiency virus 3) Other forms of liver disease (alcohol liver disease, autoimmune hepatitis etc.) 4) Decompensated cirrhosis, Liver failure 5) Severe multisystem disease, Severe immunodeficiency 6) Contraindication to pegylated interferon 7) Contraindication to ribabirin
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virologic response rate The factor associated with sustained virologic response Safety Emergence of drug-resistant virus Cumulative incidence of hepatocellular carcinoma The factor associated with incidence of hepatocellular carcinoma
- Secondary Outcome Measures
Name Time Method