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Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

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ClinicalTrials.gov Identifier: NCT02945150
Recruitment Status : Completed
First Posted : October 26, 2016
Results First Posted : February 26, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Raymond Chung, Massachusetts General Hospital

Brief Summary:
Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) Phase 4

Detailed Description:
The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a 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 : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elbasvir/grazoprevir for HCV+ kidney transplant recipients

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Drug: elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Other Name: Zepatier




Primary Outcome Measures :
  1. Number of Participants With Undetectable HCV RNA at SVR12 [ Time Frame: 12 weeks post-treatment (24 weeks post-transplant) ]
    Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.


Secondary Outcome Measures :
  1. Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365 [ Time Frame: 1 year post transplant ]
    Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365.



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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:

  1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
  2. No available living kidney donor
  3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
  4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
  5. Weight ≥ 50kg
  6. Serum alanine transaminase (ALT) within normal limits

Exclusion Criteria:

  1. AB blood type
  2. Body mass index (BMI > 35
  3. History of liver disease
  4. Pregnant or nursing (lactating) women
  5. Cardiomyopathy (LV ejection fraction < 50%)
  6. Positive crossmatch or positive donor specific antibodies
  7. Human immunodeficiency virus (HIV) positive
  8. Hepatitis C virus (HCV) RNA positive
  9. Hepatitis B virus (HBV) surface antigen positive
  10. Any contraindication to kidney transplant per MGH 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): NCT02945150


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Raymond Chung, MD Massachusetts General Hospital (Partners Healthcare)
  Study Documents (Full-Text)

Documents provided by Raymond Chung, Massachusetts General Hospital:
Publications:
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Responsible Party: Raymond Chung, Director, Hepatology, Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02945150    
Other Study ID Numbers: 2016P002051
Merck MISP 54841 ( Other Grant/Funding Number: Merck )
First Posted: October 26, 2016    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: June 9, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with study sponsor and with the hopes of publication.
Supporting Materials: Study Protocol
Time Frame: Protocol will be shared for up to 1 year after the final patient has dosed.
Access Criteria: Protocol will only be shared with Institutional Review Board (IRB) approved study staff and PI approved collaborators.

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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 Chung, Massachusetts General Hospital:
hemodialysis
peritoneal dialysis
renal failure
kidney transplant
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
MK-5172
Antiviral Agents
Anti-Infective Agents