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This research study evaluates the drug letermovir (LET or MK-8228) for prevention of cytomegalovirus (CMV) infection in pediatric patients who have received an allogeneic hematopoietic stem cell transplant (HSCT). LET has been approved in the United States and other countries for use in adults who have received an allogeneic HSCT for prevention of CMV infection and disease; however, it has not yet been approved for children who have received an allogeneic HSCT.
Subject to certain exclusion criteria, this study is enrolling pediatric patients who have received an allogeneic HSCT.
Boys and Girls: Ages birth through 17
Within 28 days after the transplant, LET will be administered either orally or intravenously, once daily through week 14 (approximately 100 days). Dosing will vary based on age, weight, and whether the participant also takes the medication cyclosporin. Blood testing will also be done at intervals to evaluate how the body processes LET, and participants will be monitored for side effects and presence of CMV.
Visits: Up to 19
Duration: About 50 weeks
Merck Sharp & Dohme
Study Description at the National Institutes of Health
Blood and Marrow Transplantation and Cellular Therapies Research
Jessie Barnum, MD
For more information about the study or enrollment, please contact:
Shawna McIntyre, Clinical Research Supervisor
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One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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