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Trial record 81 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093740
Recruitment Status : Withdrawn (Withdrew IRB application, never approved and no subjects enrolled)
First Posted : March 28, 2017
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Failure Chronic Hepatitis C Drug: Zepatier Drug: Zepatier plus Sofosbuvir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: 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
Drug: Zepatier
Based on negative viral resistance testing of the donor treatment will be Zepatier

Experimental: 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
Drug: Zepatier plus Sofosbuvir
Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir




Primary Outcome Measures :
  1. Undetectable HCV RNA [ Time Frame: 12 weeks post treatment ]
    Negative HCV viral load 12 weeks after last dose of treatment



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093740


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Raymond Chung, MD Massachusetts General Hospital

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Responsible Party: Raymond T. Chung, MD, Director, Hepatology, Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03093740     History of Changes
Other Study ID Numbers: 2017P000301
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plans to share participant data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
hemodialysis
renal failure
kidney transplant
Additional relevant MeSH terms:
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Elbasvir-grazoprevir drug combination
Hepatitis C
Renal Insufficiency
Kidney Failure, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Antiviral Agents
Sofosbuvir
Anti-Infective Agents