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Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients

NCT02781649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-09-06

Study results available
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Summary

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 Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.

Conditions

  • End-Stage Renal Disease
  • Hepatitis C

Interventions

DRUG

Zepatier

Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks

DRUG

Ribavirin

Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses

DRUG

Sofosbuvir

Sofosbuvir 400 mg daily

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-20
Primary Completion
2017-05-03
Completion
2018-01-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781649 on ClinicalTrials.gov