chronic hepatitis C
Conditions
Interventions
None listed
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients infected with hepatitis C virus genotype 1 2)Without HCC when participation 3)At least 20 years old when consent is given 4)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with a sustained virological response 24 weeks after end of treatment (SVR24). | — |
Secondary
| Measure | Time frame |
|---|---|
| (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. | — |
Countries
Japan
Contacts
Public ContactAkito Nozaki
Yokohama City University Medical Center Department of Transfusion Medicine, Gastroenterological Center
Outcome results
None listed