drugset / Trial / NCT07009548

CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients

NCT07009548

Phase 4 Enrolling by invitation 45 enrolled Fernanda P Silveira, MD, MS Kamada, Ltd. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-06-26
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytogam Protein / enzyme biologic 150 mg/kg