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

NCT ID: NCT03625687

Last Updated: 2023-04-25

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-05

Study Completion Date

2022-04-04

Brief Summary

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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

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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

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Respiratory Failure Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment with Direct Acting Antiviral for HCV

8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)

Group Type EXPERIMENTAL

Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks

Intervention Type DRUG

8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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DAA treatment Mavyret Epclusa

Eligibility Criteria

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Inclusion Criteria

* Met MGH transplant center criteria, listed for lung transplant
* Able to sign informed consent

Exclusion Criteria

* Pregnant or nursing (lactating) women
* HIV positivity
* Any contra-indication to lung transplantation per center protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raymond Chung

Director of Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond T Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018P001697

Identifier Type: -

Identifier Source: org_study_id

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