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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

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

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20209372

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