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Enrolling By Invitation
NCT07009548
CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients
Conditions: Cytomegalovirus (CMV) Infection
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 45
Sponsor: Fernanda P Silveira, MD, MS
Location: UPMC Presbyterian Pittsburgh Pennsylvania
Summary
Cytomegalovirus (CMV) is a significant opportunistic pathogen and a major cause of morbidity and mortality in solid organ transplant recipients. CytoGam - Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), is an immunoglobulin G containing a standardized amount of antibody against CMV. CytoGam is obtained from pooled adult human plasma that has been selected for high anti-CMV titers. This study will evaluate if administration of CytoGam to organ transplant recipients with CMV infection, along with standard of care antiviral medication, leads to faster clearance of CMV from the blood, prevents the development of antiviral resistance, and decreases the rate of recurrence of CMV infection.
Eligibility Criteria
Inclusion Criteria - all study arms:
* Written informed consent obtained from the subject before any trial-related procedures are performed
* \>= 18 years and \
Source: ClinicalTrials.gov (NCT07009548). StuddyBuddy aggregates publicly available trial information.