Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04614142
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
34 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Glecaprevir / Pibrentasvir Oral Tablet [Mavyret] — DRUG
    The subject will begin an 8 week course of therapy with glecaprevir (100mg) / pibrentasvir (40mg) starting on day 3 (+/- 2 days) post-kidney transplantation from a hepatitis C positive donor.

Study Details

This is a single patient, single center study evaluating if administration of pan-genotypic DAA therapy on day 3 (+/- 2 days) post-kidney transplant prevents the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Key Dates

Start date
Nov 13, 2020
Status verified
Mar 2022
Primary completion
Aug 4, 2021
Completion
Aug 4, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental: Glecaprevir/pibrentasvir for HCV+ kidney transplant recipient
    Glecaprevir (100mg) / pibrentasvir (40mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor. Subject will receive first dose on day 3 (+/- 2 days) post-kideny transplantation and continue daily for 8 weeks.

Primary Outcome Measure

Hepatitis C viral load (RNA) [ Time Frame: 20 weeks post-transplant (12-weeks post-treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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