Patients with genotype 1 HCV infection
Conditions
Interventions
None listed
Sponsors
Hokkaido University
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 1 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 protease inhibitors or NS5A inhibitor 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 who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
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 NS3, NS5A 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