Overview

CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

Status:
ENROLLING_BY_INVITATION
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
Fernanda P Silveira, MD, MS
Collaborator:
Kamada, Ltd.
Treatments:
cytomegalovirus-specific hyperimmune globulin