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

Mass General Brigham

Status and phase: Terminated; Phase 4

Conditions: End Stage Heart Disease; Hepatitis C

Treatments: Drug: Clinically prescribed direct acting antiviral

Study type: Interventional

Funder types: Other

Identifiers

NCT03208244

2017P001427

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient is Age ≥ 18 years
• Serum ALT within normal limits with no history of liver disease
• Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Exclusion criteria

• Sensitization (i.e. PRA >20%)
• Any liver disease in recipient
• Albumin < 3g/dl or platelet count < 75 x 103/mL
• Need for dual organ transplant

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment with Direct Acting Antiviral for HCV

Experimental group

Description:

12 weeks of treatment with HCV Direct Acting Antiviral tablet

Treatment:

Drug: Clinically prescribed direct acting antiviral