drugset / Trial / NCT03585101

A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk

NCT03585101

NaSingle-groupOpen-labelOther

Summary

This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). Cardiovascular disease risk will be evaluated at baseline, week 4 on treatment, 12 weeks post-treatment, and 52 weeks post-treatment through noninvasive measurements of endothelial function, insulin resistance, liver fibrosis and steatosis, and circulating blood biomarkers.

Timeline

Start
2018-08
Primary completion
2019-06
Completion
2020-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Elbasvir Small molecule 50 mg
Subject GRAZOPREVIR ANHYDROUS Small molecule 100 mg