Prospective, Randomized Study for Predicting Human Cytomegalovirus (hCMV) Infection Based on Base… (NCT02550639) | Clinical Trial Compass
CompletedPhase 4
Prospective, Randomized Study for Predicting Human Cytomegalovirus (hCMV) Infection Based on Baseline hCMV Specific T-cell Response in Kidney Transplant
Belgium, Spain160 participantsStarted 2014-02
Plain-language summary
The aim of this prospective, randomized study is to assess a subject's immunological status against hCMV before kidney transplantation by an hCMV-specific interferon (INF)-γ ELISPOT technique confirming previous results and establishing their statistical validity in order to determine whether this test could be used routinely in clinical practice to assess the risk of developing hCMV infection after renal transplantation and, ultimately, identify the most effective individual antiviral therapeutic strategy against hCMV.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be ≥ 18 years old, with a body weight \> 34 kg and of either sex or any race.
✓. Subjects must be seropositive for hCMV and must receive a renal graft from a seropositive donor (IgG positive).
✓. A pre-transplant blood sample is available from the recipient to carry out an hCMV-specific ELISPOT test.
✓. Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.
✓. Females of child bearing potential must have a pregnancy test before enrolment and be willing to use a medically acceptable birth control method during the screening period and while they receive study medication.
Exclusion criteria
✕. An inconclusive hCMV ELISPOT or unavailability of recipient samples.
✕. History of type I hypersensitivity reactions or idiosyncratic reactions to ganciclovir (GCV)/valganciclovir (VGCV).