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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2021-04-28

Brief Summary

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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.

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Detailed Description

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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

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End Stage Heart Disease Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Received heart transplant from HCV+ donor

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment with Direct Acting Antiviral for HCV

12 weeks of treatment with HCV Direct Acting Antiviral tablet

Group Type EXPERIMENTAL

Clinically prescribed direct acting antiviral

Intervention Type DRUG

HCV treatment for 12 weeks

Interventions

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Clinically prescribed direct acting antiviral

HCV treatment for 12 weeks

Intervention Type DRUG

Other Intervention Names

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DAA treatment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No