Health Condition 1: null- Chronic HCV
Conditions
Interventions
Intervention1: NA: NA
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing to provide informed consent 2. Female or male patient aged 18 years or above 3. Subjects chronically infected with hepatitis C virus (HCV) genotype 3 4. Patient found positive for HCV RNA test 5. Screening laboratory values within clinically acceptable range 6. Treatment naïve and experienced patients without cirrhosis 7. Patients who are started on daclatasvir treatment in normal clinical practice setting 8. Patients must provide written consent form to use personal and/or health data prior to the entry into the study
Exclusion criteria
Exclusion criteria: 1. HCV Genotypes other than genotype-3 infection; mixed genotype infections 2. Pregnant or nursing female or male with pregnant female partner 3. Female or male with female partner planning to become pregnant while enrolled in this study 4. Co-infection with HIV or hepatitis B virus (HBV) 5. Patients with evidence of cirrhosis or hepatocellular carcinoma 6. History of clinically significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol 7. Any contraindication for the administration of direct acting antivirals daclatasvir and sofosbuvir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess proportion of participants with SVR after 12 weeks post treatmentTimepoint: To assess proportion of participants with SVR after 12 weeks post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To understand the effect of daclatasvir use with sofosbuvir for treatment of patients with HCV Genotype 3 infection 2. To understand the effect of daclatasvir use with sofosbuvir in Treatment naïve or Treatment experienced patients without cirrhosis 3. To assess the adverse events during the study period Timepoint: 12 Weeks Post Treatment | — |
Countries
India
Contacts
Public ContactMr Altaf Makwana
Torrent Pharrnaceuticals Ltd
Outcome results
None listed