Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
Intervention1: Ledipasvir 90 mg/ sofosbuvir 400 mg: Ledipasvir 90 mg and sofosbuvir 400 mg OD orally taken for 12 or 24 weeks
Control Intervention1: Sofosbuvir: 400mg OD orally taken for 12 or 24 week
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 GT 1 or 3 infection. 5. Eligible to receive ledipasvir/sofosbuvir fixed dose combination if GT 1 and eligible to receive sofosbuvir and daclatasvir combination therapy if GT 3 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 (eg, hemochromatosis, Wilsonâ??s disease, alpha 1 antitrypsin deficiency, cholangitis) 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 (eGFR 8. Patients who are on medication that can cause bradycardia. 9. History of treatment failure to a sofosbuvir based regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of MyHep LVIRTM in chronic HCV Genotype 1 infection and of MyHepTM and MyDeklaTM combination therapy, with or without ribavirin, in chronic HCV GT 3 infectionTimepoint: 12 weeks after the 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