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QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

NCT ID: NCT04515797

Last Updated: 2024-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-08-31

Brief Summary

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This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Detailed Description

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The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

Conditions

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Kidney Failure Hepatitis C Kidney Disease, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Direct Acting Antiviral for HCV

4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant

Group Type EXPERIMENTAL

Glecaprevir and Pibrentasvir

Intervention Type DRUG

4 weeks of treatment starting within 24 hrs of kidney transplant

Interventions

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Glecaprevir and Pibrentasvir

4 weeks of treatment starting within 24 hrs of kidney transplant

Intervention Type DRUG

Other Intervention Names

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Direct Acting Antiviral HCV Treatment Mavyret

Eligibility Criteria

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Inclusion Criteria

1. Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR \<15 ml/min/1.73m2 or on renal replacement therapy)
2. Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
4. Able to sign informed consent


1. Detectable HCV NAT test
2. KDPI score is less than ≤ 0.850
3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria

1. Pregnant or nursing (lactating) women
2. HBV positivity (Ag or DNA)
3. Any contra-indication to kidney transplantation per MGH transplant center protocol
4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert


1. Confirmed HIV
2. Confirmed HBV positive (surface antigen or HBV DNA positive)
3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)
Minimum Eligible Age

18 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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Nahel Elias, M.D.

Surgical Director, Kidney Transplant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahel Elias, 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

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020P002523

Identifier Type: -

Identifier Source: org_study_id