A Non-Interventional, Multicenter, Prospective, Observational Study to UNdersTand Usage and Effect of LEdipAsvirplusSofosbuvir Combination for the Treatment of Adults with Chronic Genotype 1 HCV Infections - UNLEASH

Torrent Pharmaceuticals Ltd0 个研究点目标入组 88 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.Patient willing to provide informed consent
•2.Female or male patient aged 18 years or above
•3.Patients chronically infected with hepatitis C virus (HCV) genotype 1
•4.Patient found positive for HCV RNA test
•5.Screening laboratory values within clinically acceptable range
•6.Treatment naÃ¯ve and experienced patients with or without cirrhosis(compensated as well as decompensated)
•7.Patients who are started on ledipasvir plus sofosbuvir combination treatment in normal clinical practice setting
•8.Patients must provide written consent form to use personal and/or health data prior to the entry into the study

•1.HCV Genotypes other than genotype-1 infection; mixed genotype infections
•2.Pregnant or nursing female or male with pregnant female partner
•3.Female or male with female partner planning to become pregnant while enrolled in this study
•4.Co-infection with HIV or hepatitis B virus (HBV)
•5.Patients of hepatocellular carcinoma
•6.History of clinically significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
•7.Any contraindication for the administration of direct acting antivirals Ledipasvir and sofosbuvir
•8.Patients participating in other clinical trials

发起方

Torrent Pharmaceuticals Ltd