NCT03625687

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Detailed description

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.

Conditions

• Respiratory Failure
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks	8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)

Timeline

• Start date: 2019-02-05
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2018-08-10
• Last updated: 2023-04-25
• Results posted: 2023-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study