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

NCT04614142 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-03-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
34 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2021-08-04
Completion
2021-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04614142 on ClinicalTrials.gov