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

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant

This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Study Overview

• Status: Terminated
• Conditions: End Stage Liver Disease; Hepatitis C
• Intervention / Treatment: Drug: Treatment with Direct Acting Antiviral tablet

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 Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Masschusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Recipient is Age ≥ 18 years
• Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
• HCV naïve
• Able to sign informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Direct Acting Antiviral (DAA) 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 Names: DAA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA	Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.	12 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values	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 clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.	12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Raymond Chung, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: HCV; Epclusa; ESLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; End Stage Liver Disease; Hepatitis C; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: 2017P000653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Coded data is anticipated to be shared with potential collaborators.
• IPD Sharing 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)
• IPD Sharing Access Criteria: Data would only be shared with Institutional Review Board (IRB) approved collaborators.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• 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