Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04575896
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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 2 weeks post-renal transplant.

Key Dates

Start date
Nov 20, 2020
Status verified
Jan 2024
Primary completion
Nov 28, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
10 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 glecaprevir/pibrentasvir 300 mg/120 mg once daily by mouth for 2 weeks

Primary Outcome Measure

Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA [ Time Frame: 12 weeks after completing therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21205-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MD

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