Health Condition 1: null- Chronic Hepatitis C genotype 3 infection
Conditions
Interventions
Intervention1: Daclatasvir 60 mg and Sofosbuvir 400 mg: Daclatasvir 60 mg and Sofosbuvir 400 mg will be given to the patients as part of this Phase IV study
Control Intervention1: Not Applicable: Not
Sponsors
NATCO Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged between 19 and 60 years, both ages inclusive. Confirmed chronic HCV with genotype 3 infection (positive HCV genotyping test). Patients with 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 is equal to 10 times the ULN. Patients who are willing and able to provide written informed consent. Patients must follow adequate birth control measures from date of screening to at least 7 months from the date of stopping.
Exclusion criteria
Exclusion criteria: Patients with Hepatocellular Carcinoma Patients who are pregnant or lactating. Patients diagnosed with HIV- I & II, Hepatitis B Virus infection, psychiatric illness, unstable pulmonary or cardiac disease, seizure disorder or other serious comorbid disorders will not be included. Patients with Decompensated Cirrhosis will be excluded. Patients with Creatinine clearance less than 30 mL per minute will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the HCV RNA levels from baseline to week 12 Adverse events, vital signs, laboratory tests will be monitored during the studyTimepoint: Baseline and End of week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, vital signs, laboratory tests will be monitored during the studyTimepoint: Baseline, End of week 4, week 8 and week 12 | — |
Countries
India
Contacts
Public ContactDr Narayanasamy
Rajiv Gandhi Government General Hospital
Outcome results
None listed