A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Effectiveness and safety of Maribavir in transplant recipients with Cytomegalovirus (CMV) Infections that are resistant to treatment
Sponsor: Shire
Enrolling: Male and Female Patients
IRB Number: AAAR0147
U.S. Govt. ID: NCT02931539
Contact: Marcus Pereira: 212-305-0914 / mp2323@cumc.columbia.edu
Additional Study Information: The purpose of this research is to find out whether an experimental drug called maribivar is safe, and whether it is more effective than the medications we usually use to treat resistant CMV infections. Half of the people who choose to be part of this research study will be given maribivar, and half will be treated according to their physicians usual practice. The groups will be assigned by chance, like by a toss of a coin.The majority of people at some time in their life become infected with CMV but do not know they have it. Even with use of medicines to prevent CMV, a CMV infection or disease can still occur. Cytomegalovirus (CMV) is a viral infection and can happen in transplant patients. In patients with certain conditions such as transplant or weak defense system (a system that protects you from disease), CMV can become active and they can have symptoms of the disease. When CMV is active, it can be found in the blood. CMV infection can lead to disease involving different organs.
This study is closed
Investigator
Marcus Pereira, MD, MPH
Do You Qualify?
Have you or your child been diagnosed with CMV? Yes No
Are you or your child over the age of 12? Yes No
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Place Holder




For more information, please contact:
Marcus Pereira
mp2323@cumc.columbia.edu
212-305-0914