Cytomegalovirus (CMV) InfectionPhase 4NCT07009548
CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients
A Phase 4 study testing Cytogam in people with Cytomegalovirus (CMV) Infection, run by Fernanda P Silveira, MD, MS at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cytomegalovirus (CMV) Infection
- What is being tested?
- Cytogam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CytoGam® as Adjuvant Therapy to Prevent or Attenuate Human Cytomegalovirus (CMV) Infection and Disease in Solid Organ Transplant Recipients
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.
Read the detailed description
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.
- Conditions
- Cytomegalovirus (CMV) Infection
- Being tested
- Cytogam
- Keywords
- cytomegalovirus, CMV, CytoGam, immunoglobulin, organ transplant
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytogamDrug
Also called Cytomegalovirus Immune Globulin Intravenous, CMV-IGIV
CytoGam 150 mg/kg intravenously (IV) administered as a single dose
| Study group | Role | What they receive |
|---|---|---|
| CytoGam for primary CMV infection after lung or liver transplantation or for high viral load | Experimental | 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. Receives: Drug: Cytogam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Duration of antiviral therapy
Duration of administration of antiviral therapy
Measured: 1 year
Number of participants with de novo ganciclovir-resistance
Participants who develop laboratory-confirmed ganciclovir-resistance after CytoGam administration
Measured: 1 year
CMV recurrence
Recurrence of and time to CMV DNAemia greater than the lower limit of quantification
Measured: Within 90 days of administration of CytoGam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start26 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernanda P Silveira, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- Kamada, Ltd.
- Responsible party
- Sponsor-investigator, Fernanda P Silveira, MD, MS, University of Pittsburgh
- Investigators
- Fernanda Silveira, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009548
- Sponsor's protocol ID
- STUDY25030118
- Status last verified
- Aug 2026
- First submitted
- 29 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CytoGam® as Adjuvant Therapy to Prevent or Attenuate Human Cytomegalovirus (CMV) Infection and Disease in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT07009548
- Acronym / sponsor ID
- STUDY25030118
- Conditions
- Cytomegalovirus (CMV) Infection
- Keywords
- cytomegalovirus, CMV, CytoGam, immunoglobulin, organ transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fernanda P Silveira, MD, MSUniversity, hospital or other
- Collaborators
- Kamada, Ltd.
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CytoGam for primary CMV infection after lung or liver transplantation or for high viral load | Experimental | Drug: CytogamThere 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytogamAlso: Cytomegalovirus Immune Globulin Intravenous, CMV-IGIVCytoGam 150 mg/kg intravenously (IV) administered as a single dose | Drug | CytoGam for primary CMV infection after lung or liver transplantation or for high viral load |
Primary outcome
Time to CMV DNAemia clearance
Time frame: 1 year
Time from administration of CytoGam to CMV DNAemia clearance, defined as CMV PCR not detected or detected but below the limit of quantitation
3 secondary outcomes
Duration of antiviral therapy
Time frame: 1 year
Number of participants with de novo ganciclovir-resistance
Time frame: 1 year
CMV recurrence
Time frame: Within 90 days of administration of CytoGam
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernanda Silveira, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytogam in people with Cytomegalovirus (CMV) Infection, run by Fernanda P Silveira, MD, MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to CMV DNAemia clearance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.