Hepatitis C, Chronic Clinical Trial
Official title:
Impact of HCV Eradication on Neurocognitive Functions and CNS Metabolism: a Trial of Daclatasvir, Asunaprevir and Beclabuvir for Patients With HCV Genotype 1 Infection
The purpose of this study is to examine whether neurocognitive impairments experienced by patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing it to the end of treatment, and 4, 12 and 24 weeks after treatment.
This study will evaluate the effect of DCV/ASV/BCV on neurocognitive functioning and brain
metabolite concentrations in the frontal white matter and the basal ganglia in people with
chronic HCV genotype 1 infection, through a comparison of baseline and post-treatment
parameters.
This is an open label single arm multi-centre study. All participants will each receive
daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination
oral tablet for twice daily administration with food.
Duration of treatment will be 12 weeks for all subjects followed by 24 weeks of
observational follow-up.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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