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WITHDRAWNPHASE4

Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient

NCT03093740•Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Detailed Description

The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
•No available living kidney donor
•Recipient has ≤ 730 days of accrued transplant waiting time
•Recipient chronic hemodialysis or peritoneal dialysis
•Recipient must agree to birth control.
•°.Weigh ≥ 50kg
•Serum ALT within normal limits
•Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria

•AB Blood type
•HCV genotype 1
•BMI \> 35
•Any liver disease in recipient
•Pregnant or nursing (lactating) women
•Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
•Albumin \< 3g/dl or
•Platelet count \< 75 x 103/mL
•Positive crossmatch or positive donor specific antibodies
•HCV RNA positive
+3 more criteria

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

October 1, 2018

Primary Completion Date

December 31, 2020

Completion Date

January 31, 2021

Last Updated

December 20, 2018

Conditions

Renal Failure ChronicHepatitis C

Interventions

Zepatier

DRUG

Zepatier plus Sofosbuvir

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

View study

RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

The Outcomes of Living Donor Robotic Assisted Kidney Transplantation

The National Australian HCV Point-of-Care Testing Program

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