Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Raymond T. Chung, MD
Study ID
NCT03623568
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Key Dates

Start date
Feb 15, 2019
Status verified
May 2019
Primary completion
Dec 31, 2020
Completion
Apr 15, 2021

Study Design

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

Arms

  • Experimental: Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV
    12 weeks of treatment with Mavyret

Primary Outcome Measure

Undetectable HCV RNA in blood [ Time Frame: 12 weeks post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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