drugset / Trial / NCT03728426
Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection
NaSingle-groupOpen-labelTreatment
Summary
The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
Timeline
- Start
- 2019-01-11
- Primary completion
- 2022-03-28
- Completion
- 2022-03-28
Publications
- Background Marty FM, Ljungman P, Chemaly RF, Maertens J, Dadwal SS, Duarte RF, Haider S, Ullmann AJ, Katayama Y, Brown J, Mullane KM, Boeckh M, Blumberg EA, Einsele H, Snydman DR, Kanda Y, DiNubile MJ, Teal VL, Wan H, Murata Y, Kartsonis NA, Leavitt RY, Badshah C. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444. doi: 10.1056/NEJMoa1706640. Epub 2017 Dec 6.
- Imlay HN, Kaul DR. Letermovir and Maribavir for the Treatment and Prevention of Cytomegalovirus Infection in Solid Organ and Stem Cell Transplant Recipients. Clin Infect Dis. 2021 Jul 1;73(1):156-160. doi: 10.1093/cid/ciaa1713.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letermovir | Small molecule | 240 mg | Intravenous |
| Subject | Letermovir | Small molecule | 480 mg | Intravenous |