chronic hepatitis C
Conditions
Interventions
Orally administration of Glecaprevir(300mg)/Pibrentasvir(120mg) plus weight-based Ribavirin for 12 weeks
Sponsors
Tokai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)chronic HCV genotype1-6 infection (HCV RNA detectable) 2)History of DAA-containing treatment, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B inhibitors 3)Those who received enough explanation for the participation in this study, and obtained written consent
Exclusion criteria
Exclusion criteria: 1) Decompensated cirrhosis(jaundice,refractory ascites,hepatic encephalopathy,esophageal varices,spontaneous bacterial peritonitis) 2) Child-Pugh >6 at screening 3) Patients during treatment regardless of any type of cancer 4) Pregnancy or possible pregnancy and breast feeding 5) Patients with severe heart disease 6) Patients with haemoglobinopathies 7) The patients who meets even one any of the following, neutrophils less than 750 /mm3, platelet counts less than <50000 /mm3, Hb less than 10 g/dl 8) Patients with impaired renal function with chronic kidney failure or creatinine clearance less than 50 ml/min 9) Patient with severe mental diseases such as severe depression, the suicide consideration 10)Patients who cannot keep 6-month contraception after in the dosage and the dosage in the male patients that a partner may become pregnant 11)Patients who was judged to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sustained virologic response 12 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Virologic response at 2,4,8,12weeks and sustaind virologic response and safety | — |
Countries
Japan
Contacts
Public ContactShunji Hirose
Tokai University School of Medicine Department of Gastroenterology
Outcome results
None listed