CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

Enrolling by invitation · Phase 4

Conditions studied: Cytomegalovirus (CMV) Infection

In brief

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.

Key facts

Study ID

NCT07009548

Run by

Fernanda P Silveira, MD, MS

People needed

45

Starts

2025-06-26

Expected to finish

2027-12-01

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of hypersensitivity to or a prior severe reaction associated with the administration of CytoGam or other human immunoglobulin preparation
• Receipt of effective CMV antiviral treatment, appropriately adjusted for renal function, for greater than or equal to 14 days prior to enrollment
• Selective IgA deficiency, as they may produce antibodies against immunoglobulin A (IgA), leading to potential anaphylactic reactions upon administration of blood products containing IgA, including CMV immunoglobulin (e.g. CytoGam or similar)
• Prior history of hematopoietic cell transplant
• Pregnancy
• Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent
• Any condition which, in the judgement of the investigator, would make administration of CytoGam unsafe

Where it is running

• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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