Patients with chronic hepatitis C, who failed to DCV/ASV therapy
Conditions
Interventions
LDV/SOF plus RBV for 12 weeks
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who satisfy all the inclusion criteria and meet none of the exclusion criteria are eligible for the study. (inclusion criteria) 1) Patients with a chronic HCV infection and compensated cirrhosis who failed to DCV/ASV combination therapy 2) HCV-RNA positive 3) Patients who are 20 years of age or older at the time of informed consent 4) ECOG performance status 0 or 1 5) Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation
Exclusion criteria
Exclusion criteria: 1) HBV or HIV co-infected patients 2) Patients with a hepatocellular carcinoma, at the start of treatment 3) Patients with pregnancy, or possibility to be pregnant, or on breast feeding 4) Patients with a history of hypersensitivity to other nucleoside-analogue 5) Patients with severe renal dysfunction or need to be treated on hemodialysis 6) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia) 7) Patients with abnormal hemoglobin disease 8) Patients with severe depression, suicidal ideation, or severe mental illness 9) Patients with severe hepatic impairment 10) Patients with Autoimmune hepatitis 11) Patients taking medicine as below: rifampicin, phenytoin, carbamazepine, seiyouotogisou-including foods 12) Patients who took investigational agents within 3 months prior to this study 13) Patients who are unsuitable for study entry in the opinion of the principal investigator, for this study due to any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the sustained virologic response (SVR) rate after 12 weeks since administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) SVR 24 rates 2) Virological response rates at 1, 2, 4, 8 week and EOTR 3) Incidence of adverse effects 4) resistance-associated variant | — |
Countries
Japan
Contacts
Public ContactHiroki[0020]Ikeda
St. Marianna University School of Medicine Division of gastroenterology and Hepatology[0020]
Outcome results
None listed