Multicenter, Open Label, Prospective, Phase IV Interventional Study in Adult Indian Patients to Evaluate the Safety and Efficacy of MyHep LVIRTM (ledipasvir/sofosbuvir, Fixed Dose Combination) in HCV genotype 1 infection and the combination of MyHepTM (sofosbuvir) and MyDeklaTM (daclatasvir) in HCV genotype 3 infection - Nil

Mylan Laboratories Limited0 个研究点目标入组 501 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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 <= 8.5 g/dL (5.27 mmol/L).
•7. Patients with severe renal impairment (eGFR <45 mL/min/1.73 m2) or ESRD requiring haemodialysis.
•8. Patients who are on medication that can cause bradycardia.
•9. History of treatment failure to a sofosbuvir based regimen

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