Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
Intervention1: Velpatasvir/Sofosbuvir: FDC of Velpatasvir 100 mg and sofosbuvir 400 mg OD orally taken for 12 weeks
Control Intervention1: NIL: Not Applicable
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent. 2. Male or female, age >= 18 years. 3. Body mass index (BMI) >= 18 kg/m2 4. Confirmed chronic HCV infection. 5. Eligible to receive sofosbuvir/ velpatasvir fixed dose combination in HCV infection 6. Without clinically significant ECG abnormalities. 7. Having Child-Pugh Score <10
Exclusion criteria
Exclusion criteria: 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 co-infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV). 4. Documented or suspected Hepatocellular Carcinoma (HCC) 5. Evidence of Hepatic decompensation. 6. Patients with Hemoglobin 7. Patients with severe renal impairment 8. Patients who are on medication that can cause bradycardia. 9. History of treatment failure to a sofosbuvir based regimen 10. Patients on Medicinal products which are contraindicated to be used with sofosbuvir/ velpatasvir based combination therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of sofosbuvir/velpatasvir FDC in Adults with Chronic HCV infection up to 12 weeks after End of Treatment.Timepoint: Safety and tolerability of sofosbuvir/velpatasvir FDC in Adults with Chronic HCV infection up to 12 weeks after End of Treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained Virologic ResponseTimepoint: 12 weeks after end of treatment | — |
Countries
India
Contacts
Public ContactDr Rajesh Nachankar
Mylan Pharmaceuticals Private Limited
Outcome results
None listed