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Enrolling by invitationPhase 4

CytoGam added to antiviral treatment for CMV infection after organ transplant

Tests CytoGam with antiviral medicine in organ transplant recipients with CMV infection.

Key facts

Who runs it
Fernanda P Silveira, MD, MS
Where
Pittsburgh, United StatesSee the site
Trial code
Registry title
CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients
Status
Enrolling by invitation
Phase
Phase 4
People taking part
45 people, planned
Started
26 Jun 2025
Expected to end
Dec 2027
Type of study
Interventional
Treatments tested
  • Cytogam
Record updated
10 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a solid organ transplant who have a CMV (cytomegalovirus) infection. They get one dose of CytoGam along with usual antiviral medicine.

Age
18 to 75 years
Sex
All sexes
Disease stage
One of three groups: any organ transplant (lung, heart, liver, kidney, pancreas, intestine) on immune-lowering medicine with a high CMV level in the blood; a liver transplant with a first CMV infection; or a lung transplant with a first CMV infection after stopping CMV preventive medicine.
Earlier treatment
People cannot join if they have had effective CMV antiviral treatment for 14 days or more before enrolment. In the high viral load group, the high level must be found in the first 2 weeks of CMV antiviral treatment.
Biomarker or test result
High viral load group: CMV DNA in the blood ≥ 50,000 IU/ml. Liver and lung groups: the person had no CMV antibodies (CMV IgG negative) and got an organ from a CMV IgG positive donor (D+/R-), with any detected CMV DNA in the blood, even below the measurable limit.

Main reasons for not taking part

  • Allergy or severe reaction to CytoGam or other human immunoglobulin products
  • Selective IgA deficiency
  • Past stem cell (hematopoietic cell) transplant
  • Pregnancy
  • Taking part in another interventional trial at consent or within 30 days before

This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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
  • 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
  • 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

Who cannot take part

  • 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
  • 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
  • Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

  • UPMC PresbyterianPittsburgh, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

The group in the trial

  • CytoGam for primary CMV infection after lung or liver transplantation or for high viral loadTreatment being tested

    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.

    Treatment: Cytogam

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CytoGam® as Adjuvant Therapy to Prevent or Attenuate Human Cytomegalovirus (CMV) Infection and Disease in Solid Organ Transplant Recipients
Plain-language title
CytoGam added to antiviral treatment for CMV infection after organ transplantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07009548, who can take part
Record updated
10 August 2026