Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03208127
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief Summary:
This is a single center study for the donation of HCV-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Condition or disease Intervention/treatment Phase
End Stage Liver Disease Hepatitis C Drug: Treatment with Direct Acting Antiviral tablet Phase 4

Detailed Description:
Patients will be selected based on diminished likelihood of receiving a liver 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 MELD score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 Liver Transplant
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Direct Acting Antiviral Fixed Dose Combination
12 weeks of HCV treatment with medically appropriate direct acting antiviral
Drug: Treatment with Direct Acting Antiviral tablet
HCV Treatment for 12 Weeks
Other Name: DAA




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 direct acting antiviral [ Time Frame: 12 weeks ]
    Safety and tolerability of direct acting antiviral therapy in the liver 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • Met MGH transplant center criteria, listed for liver transplant
  • HCV naïve
  • Able to sign informed consent

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • HIV positivity
  • Need for dual organ transplant
  • Any contra-indication to liver transplantation per center protocol

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): NCT03208127


Contacts
Layout table for location contacts
Contact: Raymond Chung, MD 617-724-7562 RChung@partners.org
Contact: Jenna Gustafson, MSc 617-724-3836 JLGustafson@partners.org

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Raymond Chung, MD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03208127     History of Changes
Other Study ID Numbers: 2017P000653
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded data is anticipated to be shared with potential collaborators.
Supporting Materials: Study Protocol
Time Frame: Anticipated that data from the study will become available within 6 months after the final patient completes the primary study endpoint (12 weeks post treatment)
Access Criteria: Data would only be shared with IRB approved collaborators.

Layout table for additional information
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:
HCV
Epclusa
ESLD

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Liver Diseases
End Stage Liver Disease
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Antiviral Agents
Anti-Infective Agents