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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2021-06-04

Brief Summary

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This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

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Detailed Description

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Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Conditions

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End Stage Liver Disease 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 (DAA) Fixed Dose Combination

12 weeks of HCV treatment with medically appropriate direct acting antiviral

Group Type EXPERIMENTAL

Treatment with Direct Acting Antiviral tablet

Intervention Type DRUG

HCV Treatment for 12 Weeks

Interventions

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Treatment with Direct Acting Antiviral tablet

HCV Treatment for 12 Weeks

Intervention Type DRUG

Other Intervention Names

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DAA

Eligibility Criteria

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Inclusion Criteria

* Recipient is Age ≥ 18 years
* Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
* HCV naïve
* Able to sign informed consent

Exclusion Criteria

* Pregnant or nursing (lactating) women
* Human immunodeficiency virus (HIV) positivity
* Need for dual organ transplant
* Any contra-indication to liver transplantation per center protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No