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

Primary Purpose

Cardiac Transplant Disorder, Hepatitis C

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
Sponsored by
Raymond T. Chung, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Transplant Disorder focused on measuring Heart Transplant, Cardiac Transplant, Hepatitis C, Zepatier

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masschusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with grazoprevir + elbasvir +/- ribavirin

Arm Description

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

Outcomes

Primary Outcome Measures

Undetectable HCV
Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 13, 2017
Last Updated
December 18, 2018
Sponsor
Raymond T. Chung, MD
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03026023
Brief Title
Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
Official Title
A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raymond T. Chung, MD
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Transplant Disorder, Hepatitis C
Keywords
Heart Transplant, Cardiac Transplant, Hepatitis C, Zepatier

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with grazoprevir + elbasvir +/- ribavirin
Arm Type
Experimental
Arm Description
12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin
Intervention Type
Drug
Intervention Name(s)
Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
Other Intervention Name(s)
Zepatier
Intervention Description
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.
Primary Outcome Measure Information:
Title
Undetectable HCV
Description
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
Time Frame
12 Weeks post treatment
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Upto 16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond T Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masschusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified patient data will be shared with research collaborators for safety and data analysis.

Learn more about this trial

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

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