A Phase III Study of CMX001 versus Placebo to Prevent Cytomegalovirus (CMV) Infection in Stem Cell Transplant Recipients Already Exposed to CMV

Protocol
13-182
Full Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
Phase
III
Purpose

Cytomegalovirus (CMV) is a potential complication after stem cell transplantation. Normally, CMV may cause a mild infection that goes away without treatment. But CMV infection can be more serious after stem cell transplantation, when patients’ immune systems are weakened.

The purpose of this study is to assess the effectiveness of a new antiviral drug called CMX001 for preventing CMV infection in recipients of stem cell transplants who show evidence of previous CMV infection. Patients in this study will be randomly assigned to receive either CMX001 or a placebo (sugar pill). CMX001 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 must be recipients of a donated (allogeneic) stem cell transplant performed within 4 weeks of receiving the first dose of the study medication.
  • Patients must show evidence of prior exposure to CMV, but be negative for active CMV infection at the time of screening for the study and when receiving the first dose of the study drug.
  • This study is open to patients age 18 and older.

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

Disease(s)
Blood & Marrow Stem Cell Transplantation: Post-Transplant
Locations