At a glance
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Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection
In Brief
A Phase 4 clinical trial evaluating Valganciclovir and CMV hyperimmune globulin for Cytomegalovirus Disease. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
Study Details
Timeline
Interventions
Valcyte per package insert guidelines for 200 days post transplant
100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant
valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant