NCT03623568

Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Raymond T. Chung, MD · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a proof of concept, single center study for the donation of HCV-positive kidney 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 kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.

Conditions

• Kidney Failure
• Kidney Diseases
• Hepatitis C

Interventions

Type	Name	Description
DRUG	glecaprevir/pibrentasvir tablets	12 weeks of treatment with Mavyret

Timeline

• Start date: 2019-02-15
• Primary completion: 2020-12-31
• Completion: 2021-04-15
• First posted: 2018-08-09
• Last updated: 2019-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study