NCT07009548
CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients
Enrolling by Invitation
PHASE4Ages 18–75InterventionalTreatmentFernanda P Silveira, MD, MSInvestigator-initiated
~45 participants
Updated 2025-07-03 on ClinicalTrials.gov
What's tested:Cytogam
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to CMV DNAemia clearance
Measured over 1 year
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Fernanda Silveira, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Written informed consent obtained from the subject before any trial-related procedures are performed
\>= 18 years and \<= 75 years of age at time of consent
Able to perform routine blood testing (standard care for transplant recipients)
Understands and can read English
Recipient of an organ transplant (lung, heart, liver, kidney, pancreas, intestine alone or in combination) and on immunosuppression
CMV DNAemia ≥ 50,000 IU/ml in the first 2 weeks of CMV antiviral treatment with CMV antiviral dose appropriately adjusted for renal function
Exclusion
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
What this trial measures
- Time to CMV DNAemia clearance1 year
Time from administration of CytoGam to CMV DNAemia clearance, defined as CMV PCR not detected or detected but below the limit of quantitation