chronic hepatitis C
Conditions
Interventions
None listed
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects chronically infected with HCV genotype 1 or 2 2.At least 20-years-old at the time of providing consent 3. No documented or suspected HCC by US, CT, or MRI within 6 months prior to the screening 4.Subjects who were fully informed of and understood the objectives, procedures, and risks of the study, and who provided written voluntary consent to participate in the study
Exclusion criteria
Exclusion criteria: 1.Co-infection with hepatitis B virus or human immunodeficiency virus, other chronic liver disease 2.Evidence of hepatic decompensation (Child-Pugh classification B or C). 3.Using interferon and ribavirin during this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the regression of liver fibrosis in patients with HCV infection who have achieved SVR with sofosbuvir or ledipasvir/sofosbuvir at Week 48 after treatment initiation. Liver fibrosis was measured using multiple tests, including FastLec-Hepa and analysis of other fibrosis markers (platelet count, hyaluronic acid, the FIB-4 index, type IV collagen, Fibroscan, SWE). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the regression of liver fibrosis in patients HCV infection who have achieved SVR with sofosbuvir or ledipasvir/sofosbuvir at Week 4, 8, 12, 24, and 36 after treatment initiation (FastLec-Hepa (M2BPGi), platelet count, hyaluronic acid, the FIB-4 index, type IV collagen, Fibroscan, SWE). 2.Safety 3.SVR12 rate, SVR24 rate 4.HCC incidence rate | — |
Countries
Japan
Contacts
Public ContactAkito Nozaki
Yokohama City University Medical Center Medicine, Gastroenterological Center
Outcome results
None listed