A prospective observational study to evaluate direct acting antivirals combination therapy for chronic hepatis C.
Not Applicable
- Conditions
- chronic hepatitis C
- Registration Number
- JPRN-UMIN000015501
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Not provided
Exclusion Criteria
1)Women of childbearing potential during this study 2)Using interferon and ribavirin during this study 3)Using medicine on a CYP3A4 inducer or contraindicated to combination listed in an attached document 4)Evidence of hepatic decompensation (Child-Pugh classification B or C). 5)Otherwise found ineligible as a subject by the researcher
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients with a sustained virological response 24 weeks after end of treatment (SVR24).
- Secondary Outcome Measures
Name Time Method (1)Level of AFP and PIVKAII (2)Relation of HCC development (3)The percentage of patients with a sustained virological response 12 weeks after end of treatment (SVR12) (4)The percentage of patients whose serum HCV-RNA is undetectable at weeks 1, 2, 4, 8, 12, 16, 20, 24, 36, and 48 (5)The percentage of relapses (6)The percentage of patients with viralbreakthrough. (7)Level of FIB-4 index, other biological markers (8)Comparison with control group. (9)Relationship between IL28B genotype, IFNlambda4 genotype, HCV core mutation and efficacy.