A Study of the Safety and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
Phase: Phase 3
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01769170
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-341
The purpose of this study is to compare the effectiveness of CMX001 to placebo for the prevention of CMV infection in stem cell transplant patient who do not have CMV before starting treatment with CMX001.
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center
Francisco Marty, MD,
Brigham and Women's Hospital
James Levine, MD,
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute:
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
- Subjects will be adult allogeneic HSCT recipients aged ≥ 18 years-old (or as
applicable, per local law) who were CMV seropositive before transplantation and are
CMV viremia negative posttransplant.
- Subjects who have a positive CMV viremia test at any time between transplant and the
First Dose Day (FDD).
- Subjects with hypersensitivity (not renal dysfunction or eye disorder) to CDV or to
CMX001 or its excipients.
- Subjects who have received any anti-CMV therapy and investigational anti-CMV drugs at
any time posttransplant.
- Subjects who have had any anti-CMV vaccine at any time.