A Phase III Study of Maribavir versus Standard Treatment for Patients with Persistent CMV Infection after Stem Cell Transplantation

Full Title

SHP620-303: 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

Purpose

Cytomegalovirus (CMV) is a potential complication after stem cell transplantation that can cause serious infections, due to patients’ recovering immune systems. There are drugs used to treat CMV, but in some patients the virus becomes resistant to these drugs, or the patient cannot tolerate them.

In this study, researchers are evaluating the effectiveness of the investigational drug maribavir in patients with CMV after stem cell transplantation who are not responding well to standard CMV treatments. Maribavir works against CMV in a different way than existing medications. Smaller studies of patients have shown that it can be effective against CMV that is not responding to standard antiviral medications.

Patients in this study will be randomly assigned to receive maribavir or standard treatment. Patients who are not taking maribavir whose CMV infection continues to worsen will be able to switch treatments and take maribavir instead. Maribavir is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in this study must have CMV infection after stem cell transplantation that persists despite standard treatments.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.

Protocol

17-140

Phase

III

Investigator