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RECRUITING
NCT03886077

Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Sponsor: Sentara Norfolk General Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.

Official title: The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2019-03-20

Completion Date

2024-12-31

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

DRUG

glecaprevir/pibrentasivir

12 weeks of oral open label glecaprevir/pibrentasivir (Dose 3 tablets daily per package label).

Locations (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, United States