The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects must meet all of the inclusion criteria specified below in order to be eligible for participation in this study

‣ Willing and capable of providing written informed consent

⁃ Age ≥18 years

⁃ On UNOS list as a candidate for heart transplant

Locations
United States
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Contact Information
Primary
David Baran, MD
dabaran@sentara.com
7573882831
Backup
Gerry Cruz
gacruz@sentara.com
7573882229
Time Frame
Start Date: 2019-03-20
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 50
Treatments
Hepatitis C Negative Donor Hearts
Hearts for transplantation that are not infected with Hepatitis C. (Negative NAT)
Hepatitis C Infected Donor Hearts
Hearts for transplantation that are infected with Hepatitis C. (Positive NAT).
Related Therapeutic Areas
Sponsors
Leads: Sentara Norfolk General Hospital

This content was sourced from clinicaltrials.gov

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