Chronic hepatitis C
Conditions
Interventions
peginterferon alfa-2b, ribavirin and simeprevir plus vitamin D(prior to triple therapy)
peginterferon alfa-2b, ribavirin and simeprevir plus vitamin D(concurrent with triple therapy)
peginterferon alf
Sponsors
Hiroshima liver study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Genotype 1 and high virus load(5logIU/ml < or =)
Exclusion criteria
Exclusion criteria: 1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b and simeprevir 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) Judged by investigator not to be appropriate for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| virologic response at 4weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| virologic response at2,8,12,24 weeks Safety ( moniterd clinical and laboratory evaluation) | — |
Countries
Japan
Contacts
Public ContactYoshiiku Kawakami
graduate school of biomedical science, Hiroshima university. Department and medicine and molecular science
Outcome results
None listed