CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Valganciclovir +2 moredrug
Likely dose
CMV hyperimmune globulin 100 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01509404
NCT01509404Phase 4Completed

Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection

Medical University of South Carolina·interventional·Posted Jan 13, 2012·Updated Oct 4, 2018

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCSL Behring

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.5 years ago

Interventions

Valganciclovirdrug

Valcyte per package insert guidelines for 200 days post transplant

CMV hyperimmune globulinbiological

100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

Valganciclovirdrug

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant