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Merck begins phase 3 study of letermovir
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Enrollment has begun for a phase 3 clinical trial of the investigational antiviral agent letermovir for the prevention of cytomegalovirus infection in seropositive adult recipients of allogeneic hematopoietic stem cell transplants, according to Merck.
“There remains a need for additional therapeutic options in the prevention of [cytomegalovirus] infection in high-risk patients,” Michele Trucksis, MD, PhD, executive director of infectious diseases at Merck Research Laboratories, said in a press release.
The randomized, placebo-controlled study will evaluate the safety and efficacy of letermovir in approximately 540 patients from more than 70 centers in 20 countries, including the United States. Letermovir will be administered once daily, either as an oral tablet or IV formulation, for 14 weeks after transplant. The dosage will vary — 240 mg for patients receiving concomitant cyclosporine A and 480 mg for those not receiving cyclosporine A. The primary endpoint of the study will be the percentage of patients with cytomegalovirus infection through 24 weeks after transplant who were administered letermovir vs. placebo.
Merck estimates that the study will be completed by July 2017.
Letermovir is licensed by AiCuris GmbH & Co. KG.