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

NCT01509404 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-04

Study results available
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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

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

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509404 on ClinicalTrials.gov