Health Condition 1: null- Chronic Hepatitis C
Conditions
Interventions
Intervention1: NIL: NIL
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. Patients chronically infected with hepatitis C virus (HCV) genotype 1 4. Patient found positive for HCV RNA test 5. Screening laboratory values within clinically acceptable range 6. Treatment naïve and experienced patients with or without cirrhosis(compensated as well as decompensated) 7. Patients who are started on ledipasvir plus sofosbuvir combination 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-1 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 of 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 Ledipasvir and sofosbuvir 8. Patients participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess proportion of participants with Sustained Virological Response(SVR)Timepoint: After 12 weeks post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To understand the effect of Ledipasvir plus sofosbuvir either alone or in combination with ribavirin in HCV Genotype 1 2. To understand the effect of Ledipasvir plus sofosbuvir in Treatment naïve or Treatment experienced patients with or without cirrhosis 3. To assess the adverse events during the study period Timepoint: After 12 weeks post treatment | — |
Countries
India
Contacts
Public ContactMr Altaf Makwana
Torrent Pharmaceuticals Ltd
Outcome results
None listed