A study to see the safety of Fixed Dose Combination (FDC) of Sofosbuvir/Daclatasvir
- Conditions
- Health Condition 1: B182- Chronic viral hepatitis C
- Registration Number
- CTRI/2019/12/022216
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able to provide written informed consent
2. Male or female, age equal to or greater than 18 to equal to or less than 65 years
3. Confirmed chronic HCV genotype 3 infection
4. Eligible to receive sofosbuvir/ daclatasvir fixed dose combination in HCV genotype 3
1. Pregnant or nursing female or male with pregnant female partner not willing to use adequate physical barrier.
2. Chronic liver disease of a non-HCV etiology
3. Known coinfection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
4. Documented or suspected Hepatocellular Carcinoma (HCC)
5. Evidence of liver cirrhosis
6. Patients with adequate hemoglobin levels
7. Patients with impaired renal function
8. Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ daclatasvir based combination therapy
9. History of significant pulmonary disease, significant cardiac disease or porphyria.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse eventsTimepoint: Treatment period and up to 4 weeks after EOT
- Secondary Outcome Measures
Name Time Method 1. Percentage of subjects having the Sustained Virological Response i.e. virological response measured at SVR12 VisitTimepoint: 12 weeks after the End of Treatment