NCT03208244

DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (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 hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 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 cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.

Conditions

• End Stage Heart Disease
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Clinically prescribed direct acting antiviral	HCV treatment for 12 weeks

Timeline

• Start date: 2017-11-09
• Primary completion: 2021-04-20
• Completion: 2021-04-28
• First posted: 2017-07-05
• Last updated: 2022-06-22
• Results posted: 2022-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study