NCT01509404

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Disease

Interventions

Type	Name	Description
DRUG	Valganciclovir	Valcyte per package insert guidelines for 200 days post transplant
BIOLOGICAL	CMV hyperimmune globulin	100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant
DRUG	Valganciclovir	valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2012-01-13
• Last updated: 2018-10-04
• Results posted: 2018-10-04

Locations

1 site across 1 country: United States