Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Sentara Norfolk General Hospital
Study ID
NCT03886077
Status
Completed

Conditions

  • Coronary Artery Disease
  • Morality

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 22, 2019
Start date
Mar 20, 2019
Status verified
Apr 2026
Primary completion
Dec 20, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
50 participants (actual)

Arms

  • Arm: Hepatitis C Negative Donor Hearts
    Hearts for transplantation that are not infected with Hepatitis C. (Negative NAT)
  • Arm: Hepatitis C Infected Donor Hearts
    Hearts for transplantation that are infected with Hepatitis C. (Positive NAT).

Primary Outcome Measure

Sustained virological response at 12 weeks following therapy. [ Time Frame: 12 weeks following completion of study drug. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sentara Norfolk General HospitalNorfolkVirginia23507-

Find similar trials in Norfolk, VA

By research site
Sentara Norfolk General Hospital· Norfolk, VA

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