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Transplanting Hepatitis C Lungs Into Negative Lung Recipients — SHELTER  

Lung Diseases Clinical Trial

Official title:
Open-Labeled Trial Of Direct-acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Lung Transplants From Hepatitis C-Positive Donors

Clinical Trial Summary

This study is being conducted to determine safety and effectiveness of transplanting lungs from Hepatitis C-positive donors into Hepatitis C-negative patients on the lung transplant waitlist, who will then be treated with appropriate direct-acting antiviral (DAA) after transplantation.

Clinical Trial Description

Open-labelled pilot clinical trial of Zepatier (Grazoprevir + Elbasvir), Epclusa (Sofosbuvir + Velpatasvir), or another appropriate DAA in at least 10 HCV-negative subjects receiving a lung transplant from a hepatitis C (HCV)-positive donor. Eligible subjects will receive a lung transplant from a deceased-donor, and then will receive treatment after lung transplantation when infection with HCV is confirmed in these lung transplant recipients. Treatment will be complete after 12 weeks for most subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03724149
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 12, 2018
Completion date December 31, 2022
View Details
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