Study Stopped
Single patient the protocol was written for consented to another study.
Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a single patient, single center study evaluating if administration of pan-genotypic DAA therapy on day 3 (+/- 2 days) post-kidney transplant prevents the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2021
CompletedMarch 8, 2022
March 1, 2022
9 months
October 28, 2020
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatitis C viral load (RNA)
Negative hepatitis C viral load (RNA) tested using PCR at 12 weeks post-treatment (SVR12)
20 weeks post-transplant (12-weeks post-treatment)
Study Arms (1)
Experimental: Glecaprevir/pibrentasvir for HCV+ kidney transplant recipient
EXPERIMENTALGlecaprevir (100mg) / pibrentasvir (40mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor. Subject will receive first dose on day 3 (+/- 2 days) post-kideny transplantation and continue daily for 8 weeks.
Interventions
The subject will begin an 8 week course of therapy with glecaprevir (100mg) / pibrentasvir (40mg) starting on day 3 (+/- 2 days) post-kidney transplantation from a hepatitis C positive donor.
Eligibility Criteria
You may qualify if:
- Detectable HCV Antibody Positivity
- KDPI score is less than ≤ 0.650
- Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation at MGH
You may not qualify if:
- Donor has been known to have previously received and failed HCV treatment with a direct-acting antiviral agent
- Confirmed HIV
- Confirmed HBV positive (surface antigen or HBV DNA positive)
- Kidney anatomical damage or significant pathology noted during recovery
- Significant liver disease or signs of liver decompensation (splenomegaly, ascites) noted during recovery (advanced fibrosis or cirrhosis)
- Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection)
- Previously enrolled in IRB 2016P002051 and experienced primary graft nonfunction due to renal vein thrombosis and acute thrombotic microangiopathy
- Willing and able to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (4)
Goldberg DS, Abt PL, Blumberg EA, Van Deerlin VM, Levine M, Reddy KR, Bloom RD, Nazarian SM, Sawinski D, Porrett P, Naji A, Hasz R, Suplee L, Trofe-Clark J, Sicilia A, McCauley M, Farooqi M, Gentile C, Smith J, Reese PP. Trial of Transplantation of HCV-Infected Kidneys into Uninfected Recipients. N Engl J Med. 2017 Jun 15;376(24):2394-2395. doi: 10.1056/NEJMc1705221. Epub 2017 Apr 30. No abstract available.
PMID: 28459186BACKGROUNDReau N, Kwo PY, Rhee S, Brown RS Jr, Agarwal K, Angus P, Gane E, Kao JH, Mantry PS, Mutimer D, Reddy KR, Tran TT, Hu YB, Gulati A, Krishnan P, Dumas EO, Porcalla A, Shulman NS, Liu W, Samanta S, Trinh R, Forns X. Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. Hepatology. 2018 Oct;68(4):1298-1307. doi: 10.1002/hep.30046. Epub 2018 Jul 25.
PMID: 29672891BACKGROUNDDurand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6.
PMID: 29507971BACKGROUNDSise ME, Goldberg DS, Kort JJ, Schaubel DE, Alloway RR, Durand CM, Fontana RJ, Brown RS Jr, Friedewald JJ, Prenner S, Landis JR, Fernando M, Phillips CC, Woodle ES, Rike-Shields A, Sherman KE, Elias N, Williams WW, Gustafson JL, Desai NM, Barnaba B, Norman SP, Doshi M, Sultan ST, Aull MJ, Levitsky J, Belshe DS, Chung RT, Reese PP. Multicenter Study to Transplant Hepatitis C-Infected Kidneys (MYTHIC): An Open-Label Study of Combined Glecaprevir and Pibrentasvir to Treat Recipients of Transplanted Kidneys from Deceased Donors with Hepatitis C Virus Infection. J Am Soc Nephrol. 2020 Nov;31(11):2678-2687. doi: 10.1681/ASN.2020050686. Epub 2020 Aug 25.
PMID: 32843477BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Hepatology and Liver Center
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
November 13, 2020
Primary Completion
August 4, 2021
Study Completion
August 4, 2021
Last Updated
March 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Data will not be shared outside of the research team.