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Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant

NCT ID: NCT03026023

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-06-30

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 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.

Detailed Description

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Phase 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients.

Patients will be selected based on their diminished likelihood of receiving a heart 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 listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.

Conditions

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Cardiac Transplant Disorder Hepatitis C

Keywords

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Heart Transplant Cardiac Transplant Hepatitis C Zepatier

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 grazoprevir + elbasvir +/- ribavirin

12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin

Group Type EXPERIMENTAL

Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin

Intervention Type DRUG

HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.

Interventions

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Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin

HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.

Intervention Type DRUG

Other Intervention Names

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Zepatier

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

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Raymond T. Chung, MD

OTHER

Sponsor Role lead

Responsible Party

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Raymond T. Chung, MD

Director of Hepatology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Raymond T Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Masschusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2017P000074

Identifier Type: -

Identifier Source: org_study_id