An explosive study on add-on effects of ribavirin in sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy.
Not Applicable
- Conditions
- Patients with chronic HCV infection, who failed to DCV/ASV therapy
- Registration Number
- JPRN-UMIN000020009
- Lead Sponsor
- Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
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, Ribavirin and NS5A inhibitors 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 renal dysfunction eGFR 50 ml/min 7)Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the sustained virologic response (SVR) rate at follow-up Week 12
- Secondary Outcome Measures
Name Time Method Effects of HCV NS5A/B 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) Incidence of AEs