Coronary Artery Disease Clinical Trial
— SHERPAOfficial title:
The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects must meet all of the inclusion criteria specified below in order to be eligible for participation in this study 1. Willing and capable of providing written informed consent 2. Age =18 years 3. On UNOS list as a candidate for heart transplant Exclusion Criteria: - Subjects who meet any of the following exclusion criteria cannot be enrolled in this study. 1. Individuals under 18 years of age 2. History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis 3. Pregnant individuals 4. HIV antibody positive |
Country | Name | City | State |
---|---|---|---|
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Sentara Norfolk General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sustained virological response at 12 weeks following therapy. | 12 weeks after the completion of drug that the patient no longer has Hepatitis C. | 12 weeks following completion of study drug. | |
Secondary | Coronary allograft vasculopathy at 1 year post transplant. | Presence of coronary disease at 1 year post heart transplant. | 1 Year post heart transplant. |
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