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

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ClinicalTrials.gov Identifier: NCT03208244
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : March 5, 2019
Sponsor:
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 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Condition or disease Intervention/treatment Phase
End Stage Heart Disease Hepatitis C Drug: Clinically prescribed direct acting antiviral Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Direct Acting Antiviral for HCV
12 weeks of treatment with HCV Direct Acting Antiviral tablet
Drug: Clinically prescribed direct acting antiviral
HCV treatment for 12 weeks
Other Name: DAA treatment




Primary Outcome Measures :
  1. Undetectable HCV RNA [ 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 DAA therapy in patients undergoing cardiac transplantation [ Time Frame: 12 weeks ]
    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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03208244


Contacts
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Contact: Raymond Chung, MD 617-724-7562 RChung@partners.org
Contact: Jenna L Gustafson, MSc 617-724-3836 JLGustafson@partners.org

Locations
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United States, Massachusetts
Masschusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jenna L Gustafson, MS    617-724-3836    jlgustafson@partners.org   
Contact: Raymond T Chung, MS       rchung@partners.org   
Sub-Investigator: Emily Bethea, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Raymond L Chung, MD Massachusetts General Hospital

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Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03208244     History of Changes
Other Study ID Numbers: 2017P001427
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anticipate to share coded data with collaborators
Supporting Materials: Study Protocol
Time Frame: Anticipate data would be available to share within 6 months after the final patient completes the study.
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.

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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 Disease
Heart Transplant
HCV
Hepatitis C

Additional relevant MeSH terms:
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Hepatitis
Hepatitis C
Heart Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Cardiovascular Diseases
Antiviral Agents
Anti-Infective Agents