CytoGam for CMV Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether CytoGam, an immune-boosting treatment, can help organ transplant recipients combat cytomegalovirus (CMV), a common infection that can be serious for them. The study examines if adding CytoGam to standard antiviral drugs clears the virus faster, prevents its recurrence, and stops drug resistance. It seeks participants who recently had a lung or liver transplant, are dealing with a CMV infection, and have not been on antiviral treatment for more than two weeks. As a Phase 4 trial, CytoGam is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will receive CytoGam along with standard antiviral medication, so you may continue your current antiviral treatment.
What is the safety track record for CytoGam?
Previous studies have shown CytoGam to be safe. Fewer than 6% of recipients experienced side effects, which were mostly mild, such as headaches or a slight fever. Serious reactions are rare but can occur, particularly in those allergic to similar treatments. The FDA has approved CytoGam for preventing CMV in other organ transplants, indicating a strong safety record.12345
Why are researchers enthusiastic about this study treatment?
CytoGam is unique because it offers a specialized approach to managing CMV infections, especially after organ transplants. Unlike standard antiviral medications like valganciclovir, which are often used for CMV prophylaxis or treatment, CytoGam is an immunoglobulin product specifically designed to target CMV by providing immediate passive immunity. This can be particularly beneficial for patients who have developed a high viral load or CMV DNAemia after transplant, offering a potentially quicker and targeted response. Researchers are excited about its ability to complement existing antiviral therapies and possibly enhance overall patient outcomes in transplant settings.
What is the effectiveness track record for CytoGam in treating CMV infection?
Research has shown that CytoGam, which participants in this trial will receive, can help reduce problems caused by CMV (cytomegalovirus) in organ transplant recipients. One study found that CytoGam lowers the chances of CMV disease in lung transplant patients and helps clear the virus from the blood more quickly. It outperforms standard treatments due to its high concentration of CMV-fighting antibodies. Since CytoGam is already approved for certain uses, there is confidence in its ability to manage CMV infections in transplant patients.678910
Who Is on the Research Team?
Fernanda Silveira, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for solid organ transplant recipients who are dealing with CMV infection or disease. Participants should not have other active infections and must be able to receive intravenous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one dose of CytoGam and antiviral therapy as per physician's discretion
Follow-up
Participants are monitored until 2 weekly negative CMV PCRs, discontinuation of antiviral, or 1 year from CytoGam infusion
What Are the Treatments Tested in This Trial?
Interventions
- CytoGam
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fernanda P Silveira, MD, MS
Lead Sponsor
Kamada, Ltd.
Industry Sponsor