A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and Effect of Daclatasvir use with Sofosbuvir for the TrEatmenT of Adults with Chronic Genotype 3 HCV Infections - DETACH

Torrent Pharmaceuticals Ltd0 个研究点目标入组 54 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.Subjects chronically infected with hepatitis C virus (HCV) genotype 3
•4.Patient found positive for HCV RNA test
•5.Screening laboratory values within clinically acceptable range
•6.Treatment naÃ¯ve and experienced patients without cirrhosis
•7.Patients who are started on daclatasvir 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-3 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 with evidence of cirrhosis or 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 daclatasvir and sofosbuvir

发起方

Torrent Pharmaceuticals Ltd