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ENROLLING BY INVITATION

NCT07009548

PHASE4

CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

Sponsor: Fernanda P Silveira, MD, MS

View on ClinicalTrials.gov

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.

Official title: CytoGam® as Adjuvant Therapy to Prevent or Attenuate Human Cytomegalovirus (CMV) Infection and Disease in Solid Organ Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-26

Completion Date

2027-12

Last Updated

2025-07-03

Healthy Volunteers

Conditions

Cytomegalovirus (CMV) Infection

Interventions

DRUG

Cytogam

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

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

Locations (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States