Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

December 18, 2018 updated by: Raymond T. Chung, MD, Massachusetts General Hospital

Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient

Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
  • No available living kidney donor
  • Recipient has ≤ 730 days of accrued transplant waiting time
  • Recipient chronic hemodialysis or peritoneal dialysis

  • Recipient must agree to birth control.

    °.Weigh ≥ 50kg

  • Serum ALT within normal limits
  • Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria:

  • AB Blood type
  • HCV genotype 1
  • BMI > 35
  • Any liver disease in recipient
  • Pregnant or nursing (lactating) women
  • Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
  • Albumin < 3g/dl or
  • Platelet count < 75 x 103/mL
  • Positive crossmatch or positive donor specific antibodies
  • HCV RNA positive
  • Hepatitis B surface antigen positive
  • Patients with primary focal segmental glomerulosclerosis (FSGS)
  • Any contra-indication to kidney transplantation per our center protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCV treatment - no viral resistance
Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier
Drug: Zepatier
Based on negative viral resistance testing of the donor treatment will be Zepatier
Experimental: HCV treatment - viral resistance
Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir
Drug: Zepatier plus Sofosbuvir
Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable HCV RNA
Time Frame: 12 weeks post treatment
Negative HCV viral load 12 weeks after last dose of treatment
12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plans to share participant data

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Zepatier

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe