A Study for the Use of Hepatitis C Virus Seropositive Donors into Hepatitis C Seronegative Liver Transplant Recipients

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-002044
    • Scottsdale/Phoenix, Arizona: 17-002044
    • Jacksonville, Florida: 17-002044
    Sponsor Protocol Number: 17-002044

About this study

The purpose of this study is to utilize liver allografts from HCV seropositive donors into 10 HCV seronegative recipients. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Listed patients who are negative for HCV RNA
  • Ages 40-65
  • MELD score 15-34
  • No contra-indications to direct acting antiviral therapy
  • Not a candidate for a living donor allograft
  • Deemed by transplant team to have complication of liver disease refractory to medical therapy or high risk of death and unlikely to receive a liver transplant in the next 24 to 48 weeks
  • There are no HCV positive recipients who could accept the donor liver

Exclusion Criteria

  • Previous HCV treatment
  • HIV or Chronic Hepatitis B.
  • DCD or ABO incompatible Donor
  • Donor on HCV or with history treatment
  • Biopsy of donor liver demonstrating > stage 2 fibrosis.
  • Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
  • Hepatocellular carcinoma outside of accepted institutional criteria

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rolland Dickson, M.D.

Closed for enrollment

Contact information:

Adam Miller

(507)266-8147

Miller.Adam@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rolland Dickson, M.D.

Closed for enrollment

Contact information:

Megan Kelly

(480)342-1248

Kelly.Megan1@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Rolland Dickson, M.D.

Closed for enrollment

Contact information:

Surakit Pungpapong M.D.

(904)956-3200

Pungpapong.Surakit@mayo.edu

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CLS-20387113

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