Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 12-005603
    NCT ID: NCT01552369
    Sponsor Protocol Number: DMID 11-0073

About this study

This is a study of two different approaches for the prevention of CMV disease in liver transplant recipients. The primary purpose is to determine if Preemptive therapy is the same or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative recipients that receive a CMV positive liver transplant. Patients meeting study criteria and who have provided informed consent will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV viremia by plasma PCR) for 100 days with initiation of oral valganciclovir 900mg orally twice daily only at onset of CMV viremia and continued until plasma PCR is negative on two consecutive weekly PCR tests.

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:

  • Greater than 18 yrs of age
  • Negative CMV serology recipient
  • Positive CMV serology donor
  • Liver transplant within 10 days
  • Absolute neutrophil count>1000
  • Female subjects of childbearing potential must have negative pregnancy test and agree to use effective contraception during and for 3 months after receipt of valganciclovir
  • Male subjects, that have not had a vasectomy, must agree to practice barrier method of contraception during and for 3 months after receipt of valganciclovir

Exclusion Criteria:

  • Enrollment in other investigational drug trials
  • Hypersensitivity to acyclovir, ganciclovir or valganciclovir
  • Breast feeding mother
  • HIV infection
  • Multiple organ transplant or re-transplantation
  • Life expectancy of less than 72 hours

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymund Razonable, M.D.

Closed for enrollment

Contact information:

Adam Miller

(507)266-8147

Miller.Adam@mayo.edu

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CLS-20209372

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