Can an antibody boost help transplant patients beat CMV faster?
NCT ID NCT07009548
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests whether adding a single dose of CytoGam—a concentrated antibody product against cytomegalovirus (CMV)—to standard antiviral drugs helps clear CMV from the blood faster in solid organ transplant recipients. The study enrolls adults aged 18–75 who have received an organ transplant and have CMV infection. Researchers will measure how quickly the virus disappears, whether antiviral resistance develops, and if CMV comes back after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), also known as CytoGam, given as a single intravenous dose alongside standard antiviral medication
- What this could lead to
- If effective, adding CytoGam to standard antivirals could speed up CMV clearance, reduce antiviral resistance, and lower recurrence risk in transplant recipients.
- What could go wrong
- This is a small phase 4 trial (45 participants), so results may not apply broadly. The single-dose approach may not provide lasting benefit, and infusion-related reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria - all study arms: * 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 Inclusion criteria - high viral load arm: * 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 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: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
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