An open label, multicenter, Phase-IV clinical trial to evaluate the safety and efficacy of Daclatasvir and Sofosbuvir in patients with Chronic Hepatitis C genotype 3 infection.
- Conditions
- Health Condition 1: null- Chronic Hepatitis C genotype 3 infection
- Registration Number
- CTRI/2018/03/012297
- Lead Sponsor
- ATCO Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the HCV RNA levels from baseline to week 12 <br/ ><br>Adverse events, vital signs, laboratory tests will be monitored during the studyTimepoint: Baseline and End of week 12
- Secondary Outcome Measures
Name Time Method Adverse events, vital signs, laboratory tests will be monitored during the studyTimepoint: Baseline, End of week 4, week 8 and week 12