NCT03523871

A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Mavyret	Patients will be on 8 weeks of Mavyret

Timeline

• Start date: 2018-05-12
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2018-05-14
• Last updated: 2021-09-05
• Results posted: 2021-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study