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Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV) | Clinical Trials | Clareo Health

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Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)

Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors

NCT03146741•University of Pennsylvania

View on ClinicalTrials.gov

Summary

This study is being conducted to determine safety and effectiveness of transplanting hearts from Hepatitis C-positive donors into Hepatitis C-negative patients on the heart transplant waitlist, who will then be treated with Zepatier after transplantation.

Detailed Description

Open-labelled pilot clinical trial of Zepatier (MK-5172 and MK-8742/Grazoprevir + Elbasvir) in at least 20 HCV-negative subjects receiving a heart transplant from a HCV-positive donor. Eligible subjects will receive a heart transplant from a deceased-donor with genotype 1 or 4 HCV, and then will receive 12 weeks of Zepatier after heart transplantation when infection with HCV is confirmed in these heart transplant recipients. Treatment will be complete after 12 weeks.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•New York Heart Association (NYHA) Class III or IV CHF refractory to maximal medical therapy (ACE inhibitor, B-blocker, digoxin and diuretics, resynchronization therapy or Implantable Cardioverter Defibrillator when applicable) and/or conventional surgery.
•Inoperable coronary artery disease with intractable anginal symptoms
•Malignant ventricular arrhythmias unresponsive to medical or surgical therapy
•18-65 years of age
•Obtained agreement for participation from the transplant cardiology team
•No evident contraindication to liver transplantation other than the underlying cardiac disorder
•Able to travel to the University of Pennsylvania for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
•No active illicit substance abuse
•Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) following transplant due to the increased risk of birth defects and/or miscarriage
•Both men and women must agree to use at least one barrier method of birth control or remain abstinent following transplant due to risk of HCV transmission
+1 more criteria

Exclusion Criteria

•Hepatocellular carcinoma
•HIV positive
•HCV antibody positive and/or RNA positive
•Hepatitis B surface antigen, core antibody, and/or DNA positive
•Any other chronic liver disease (excluding non-alcoholic fatty liver disease (NAFLD) with abnormal liver enzymes
•Persistently elevated liver transaminases
•Congenital heart disease
•Fibrosis by liver biopsy or total bilirubin \> 2.5 with associated evidence of synthetic dysfunction.
•Pregnant or nursing (lactating) women
•Known allergy or intolerance to tacrolimus that would require post-transplant administration of cyclosporine, rather than tacrolimus given the drug-drug interaction between cyclosporine and ZEPATIER
+48 more criteria

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

May 16, 2017

Primary Completion Date

September 10, 2019

Completion Date

November 30, 2019

Last Updated

November 22, 2021

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Zepatier

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)

Inclusion Criteria

Exclusion Criteria

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