Phase IV clinical trial to know the side effects and response of Daclatasvir 60 mg & Sofosbuvir 400 mg tablets in patients with Chronic Hepatitis C genotype 3 infectio
- Conditions
- Health Condition 1: B182- Chronic viral hepatitis C
- Registration Number
- CTRI/2019/11/021975
- Lead Sponsor
- atco Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the HCV RNA levelsTimepoint: week 1 week 12 and week 24
- Secondary Outcome Measures
Name Time Method Adverse event monitoringTimepoint: week 1 and week 24