Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03627299
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 300mg glecaprevir/pibrentasivir 120mg — DRUG
    300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant

Study Details

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant.

Key Dates

First listed
Aug 13, 2018
Start date
Sep 25, 2018
Status verified
Sep 2021
Primary completion
Dec 19, 2019
Completion
Sep 20, 2021

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Deceased donor HCV RNA PCR+
    Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks

Primary Outcome Measure

Viral Response at Week 12 [ Time Frame: 12 weeks after completing therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205-

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By research site
Johns Hopkins University· Baltimore, MD

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