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

NCT ID: NCT03093740

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Renal Failure Chronic Hepatitis C

Keywords

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hemodialysis renal failure kidney transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HCV treatment - no viral resistance

Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier

Group Type EXPERIMENTAL

Zepatier

Intervention Type DRUG

Based on negative viral resistance testing of the donor treatment will be Zepatier

HCV treatment - viral resistance

Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir

Group Type EXPERIMENTAL

Zepatier plus Sofosbuvir

Intervention Type DRUG

Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

Interventions

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Zepatier

Based on negative viral resistance testing of the donor treatment will be Zepatier

Intervention Type DRUG

Zepatier plus Sofosbuvir

Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

Intervention Type DRUG

Eligibility Criteria

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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
* Hepatitis B surface antigen positive
* Patients with primary focal segmental glomerulosclerosis (FSGS)
* Any contra-indication to kidney transplantation per our center protocol
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raymond T. Chung, MD

Director, Hepatology, Massachusetts General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2017P000301

Identifier Type: -

Identifier Source: org_study_id