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Study of Hepatitis Eradication Receiving Protease Inhibitor Administration
Sponsor: Sentara Norfolk General Hospital
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
Conditions
Interventions
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