Patients with genotype 2 HCV infection
Conditions
Interventions
None listed
Sponsors
Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study. (1) Subjects Patients with a chronic HCV infection and compensated cirrhosis who are being treated as outpatients or inpatients at institutions participating in this study (2) Inclusion criteria [1] Patients who are 20 years of age or older at the time of informed consent [2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation [3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Exclusion criteria
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 NS5B 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Effects of HCV NS5B 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 | — |
Countries
Japan
Contacts
Public ContactGoki Suda
Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Outcome results
None listed