A Phase 4 interventional study of Cytogam in Cytomegalovirus (CMV) Infection, sponsored by Fernanda P Silveira, MD, MS. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Fernanda P Silveira, MD, MS · Phase 4, Interventional, and Treatment
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.
Interventional, open-label, single center, pilot study to test the effect of CytoGam on CMV viremia clearance in organ transplant recipients with high CMV viral load and in CMV D+/R- lung and liver transplant recipients with primary CMV infection.
CMV D+/R- lung transplant recipients who develop any level of CMV DNAemia after discontinuation of valganciclovir prophylaxis and who have not yet received antiviral treatment for greater than 14 days will receive one dose of CytoGam. The choice and duration of antiviral therapy will be at the discretion of the treating physician. Patients will be followed until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion, whichever is longer.
CMV D+/R- liver transplant recipients on pre-emptive therapy who develop any level of detectable CMV DNAemia and who have not yet received antiviral treatment for greater than 14 days will receive one dose of CytoGam. The choice and duration of antiviral therapy will be at the discretion of the treating physician. Patients will be followed until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion, whichever is longer.
Recipients of any solid organ transplant who have CMV DNAemia ≥ 50,000 IU/ml, with or without CMV disease, and who have not yet received antiviral therapy for greater than 14 days will receive one dose of CytoGam. The choice and duration of antiviral therapy will be at the discretion of the treating physician. Patients will be followed until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion, whichever is longer.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
This study's planned enrollment of 45 is below the median of 64 across 240 interventional studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →Fernanda P Silveira, MD, MS is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Inclusion Criteria - all study arms:
Inclusion criteria - high viral load arm:
Inclusion criteria - CMV primary infection after liver transplantation arm:
- Liver transplant recipients who are CMV IgG negative and received a CMV IgG positive donor (CMV D+/R-) with a primary CMV infection, defined as detected CMV DNAemia, including detected but below the limit of quantitation
Inclusion criteria - CMV primary infection after lung transplantation arm:
- Lung transplant recipients who are CMV D+/R- with a primary CMV infection after discontinuation of CMV antiviral prophylaxis, defined as detected CMV DNAemia, including detected but below the limit of quantitation
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There are 3 cohorts in this treatment arm: * CMV D+/R- lung transplant recipients who develop any level of CMV DNAemia after discontinuation of valganciclovir prophylaxis and who have not yet received antiviral treatment for greater than 14 days will receive one dose of CytoGam. * CMV D+/R- liver transplant recipients on pre-emptive therapy who develop any level of detectable CMV DNAemia and who have not yet received antiviral treatment for greater than 14 days will receive one dose of CytoGam. * Recipients of any solid organ transplant who have CMV DNAemia ≥ 50,000 IU/ml, with or without CMV disease, and who have not yet received antiviral therapy for greater than 14 days will receive one dose of CytoGam. For all cohorts the choice and duration of antiviral therapy will be at the discretion of the treating physician.
Drug: Cytogam
CytoGam 150 mg/kg intravenously (IV) administered as a single dose
Also known as: Cytomegalovirus Immune Globulin Intravenous, CMV-IGIV
Time to CMV DNAemia clearance
Time from administration of CytoGam to CMV DNAemia clearance, defined as CMV PCR not detected or detected but below the limit of quantitation
Time frame: 1 year
Duration of antiviral therapy
Duration of administration of antiviral therapy
Time frame: 1 year
Number of participants with de novo ganciclovir-resistance
Participants who develop laboratory-confirmed ganciclovir-resistance after CytoGam administration
Time frame: 1 year
CMV recurrence
Recurrence of and time to CMV DNAemia greater than the lower limit of quantification
Time frame: Within 90 days of administration of CytoGam
Plan to share: No — We do not plan to share individual participant data outside of our investigative team and collaborators. Aggregate data will be shared in publications as appropriate.
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Studies of the drug tested here: Cytomegalovirus-specific hyperimmune globulin
Fernanda P Silveira, MD, MS