Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy
- Conditions
- Patients with chronic hepatitis C, who failed to DCV/ASV therapy
- Registration Number
- JPRN-UMIN000021790
- Lead Sponsor
- St. Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the sustained virologic response (SVR) rate after 12 weeks since administration
- Secondary Outcome Measures
Name Time Method 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