drugset / Trial / NCT05895448

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

NCT05895448

Phase 4 Unknown 125 enrolled Center For Hepatitis C, Atlanta, GA
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded. Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.

Timeline

Start
2018-03-01
Primary completion
2023-11-01
Completion
2024-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sofosbuvir Small molecule 400 mg
Subject velpatasvir Other / unclassified 100 mg