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

Primary Purpose

End Stage Heart Disease, Hepatitis C

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clinically prescribed direct acting antiviral
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Heart Disease focused on measuring Heart Disease, Heart Transplant, HCV, Hepatitis C

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 Direct Acting Antiviral for HCV

Arm Description

12 weeks of treatment with HCV Direct Acting Antiviral tablet

Outcomes

Primary Outcome Measures

Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Secondary Outcome Measures

Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation
Safety and tolerablity of commercially available DAA therapy 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
July 3, 2017
Last Updated
June 1, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03208244
Brief Title
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Official Title
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Protocol transitioned to standard of care, no funding available to support research work
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

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
No

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 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Detailed Description
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Heart Disease, Hepatitis C
Keywords
Heart Disease, Heart Transplant, HCV, Hepatitis C

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Received heart transplant from HCV+ donor
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Direct Acting Antiviral for HCV
Arm Type
Experimental
Arm Description
12 weeks of treatment with HCV Direct Acting Antiviral tablet
Intervention Type
Drug
Intervention Name(s)
Clinically prescribed direct acting antiviral
Other Intervention Name(s)
DAA treatment
Intervention Description
HCV treatment for 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
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
Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation
Description
Safety and tolerablity of commercially available DAA therapy 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
12 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 L 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
Anticipate to share coded data with collaborators
IPD Sharing Time Frame
Anticipate data would be available to share within 6 months after the final patient completes the study.
IPD Sharing Access Criteria
Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.
Citations:
PubMed Identifier
31353243
Citation
Bethea ED, Gaj K, Gustafson JL, Axtell A, Lebeis T, Schoenike M, Turvey K, Coglianese E, Thomas S, Newton-Cheh C, Ibrahim N, Carlson W, Ho JE, Shah R, Nayor M, Gift T, Shao S, Dugal A, Markmann J, Elias N, Yeh H, Andersson K, Pratt D, Bhan I, Safa K, Fishman J, Kotton C, Myoung P, Villavicencio MA, D'Alessandro D, Chung RT, Lewis GD. Pre-emptive pangenotypic direct acting antiviral therapy in donor HCV-positive to recipient HCV-negative heart transplantation: an open-label study. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):771-780. doi: 10.1016/S2468-1253(19)30240-7. Epub 2019 Jul 26.
Results Reference
derived

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

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