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Trial record 18 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03026023
Recruitment Status : Withdrawn (moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved)
First Posted : January 20, 2017
Last Update Posted : December 20, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Transplant Disorder Hepatitis C Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Treatment with grazoprevir + elbasvir +/- ribavirin
12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin
Drug: 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.
Other Name: Zepatier

Primary Outcome Measures :
  1. Undetectable HCV [ Time Frame: 12 Weeks post treatment ]
    Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Secondary Outcome Measures :
  1. Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation [ Time Frame: Upto 16 Weeks ]
    Safety and tolerability of grazoprevir and elbasvir in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03026023

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United States, Massachusetts
Masschusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Raymond T. Chung, MD
Merck Sharp & Dohme Corp.
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Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital

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Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital Identifier: NCT03026023     History of Changes
Other Study ID Numbers: 2017P000074
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified patient data will be shared with research collaborators for safety and data analysis.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
Heart Transplant
Cardiac Transplant
Hepatitis C
Additional relevant MeSH terms:
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Elbasvir-grazoprevir drug combination
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents