CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

NCT07009548 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: STUDY25030118
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cytomegalovirus (CMV) Infection

Keywords

cytomegalovirus; CMV; CytoGam; immunoglobulin; organ transplant

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

• Duration of antiviral therapy

  1 year

• Number of participants with de novo ganciclovir-resistance

  1 year

• CMV recurrence

  Within 90 days of administration of CytoGam

Study Arms (1)

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.

Drug: Cytogam

Interventions

Cytogam DRUG

CytoGam 150 mg/kg intravenously (IV) administered as a single dose

Also known as: Cytomegalovirus Immune Globulin Intravenous, CMV-IGIV

CytoGam for primary CMV infection after lung or liver transplantation or for high viral load

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fernanda P Silveira, MD, MS: lead
• Kamada, Ltd.: collaborator

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

cytomegalovirus-specific hyperimmune globulin

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Fernanda Silveira, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)