A Study on Predictors of Treatment Response to Simeprevir, Peg-interferon and Ribavirin combination therapyin Patients with genotype Chronic Hepatitis C Virus Infectio
Not Applicable
- Conditions
- Patients with genotype 1 HCV infection
- Registration Number
- JPRN-UMIN000020295
- Lead Sponsor
- Hokkaido University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia) 2)Patients with severe hepatic impairment 3)Patients with a history of hypersensitivity to HCV protease inhibitors or Ribavirin 4)Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment 5)Patients deemed unsuitable for study entry by their treating physician 6) Patients with severe renal dysfunction 7)Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the predictors obtained at baseline and affecting the sustained virologic response (SVR) rate/occurrence of adverse drug reactions at follow-up Week 12
- Secondary Outcome Measures
Name Time Method Effects of HCV NS3/4 mutations as viral factors on virologic response 2)Rate of emergence of drug-resistant variants 3)Presence or absence of a reversal of liver fibrosis 4)Presence or absence of an improvement in AFP levels 5)Effects of glucose/lipid-related factors on treatment response 6) Incidence of AEs