patients with HCV infection
Conditions
Interventions
None listed
Sponsors
Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with chronic hepatitis or compensated cirrhosis 2)Child-Pugh Score 5 or 6 3)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 4)Adequate functional reserve of major organs 5)Over 20 years old 6)Capable of complying with requirements with respect to visit days, medication, and laboratory tests 7)The patient provides written informed consent before the start of the clinical study
Exclusion criteria
Exclusion criteria: 1)History of hypersensitivity to any component of the study drug 2)Receiving contraindicated drugs for Elbasvir/Grazoprevir combined therapy 3)Esophageal varices with the potential to bleed 4)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder 5)Patients with active hepatocellular carcinoma 6)Patients with brain tumor 7)Patients with active double cancer 8)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease 9)Pregnant or nursing 10)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety 2.Factors in patients who failed to antiviral therapy 3.Changes in lipid metabolism | — |
Countries
Japan
Contacts
Public ContactNoriyuki Akutsu
Sapporo Medical University School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed