Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
Intervention1: Hepcinat Plus: (Daclatasvir 60 mg + Sofosbuvir 400 mg) Tablets
Route: oral
Frequency: daily once
Total Duration: 24 weeks
Control Intervention1: NOT Applicable: NOT Applicable
Sponsors
Natco Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Confirmed chronic HCV with genotype 3 infection (positive HCV genotyping test) 2.Patients with the following haematological and biochemical laboratory variables: A neutrophil count of 1.5 x 109/L, haemoglobin concentration of 11 g/dl or higher in women or 12 g/dl or higher in men, a platelet count of greater than 90 x 109/L, total bilirubin within two times the upper limit of normal (21 µmol/L), ALT less than or equal to 10 times the upper limit of normal (ULN), AST less than or equal to 10 times the ULN 3.Patients who are willing and able to provide written informed consent 4.Patients must follow adequate birth control measures from the date of screening to at least 7 months from the date of stopping the study drug 5.Patients with Compensated liver cirrhosis
Exclusion criteria
Exclusion criteria: 1. Patients with Hepatocellular Carcinoma 2. Patients who are pregnant or lactating 3.Patients diagnosed with HIV- I & II Hepatitis B Virus infection, psychiatric illness, unstable pulmonary or cardiac disease seizure disorder or other serious comorbid disorders 4.Decompensated Cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the HCV RNA levelsTimepoint: week 1 week 12 and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event monitoringTimepoint: week 1 and week 24 | — |
Countries
India
Contacts
Public ContactDr Dharmesh Kapoor
Global Hospitals
Outcome results
None listed