NCT05914675

Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After R+HID-HSCT

Efficacy and Safety of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection After HLA-haploidentical Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of primary prophylaxis of CMV reactivation, clinically significant CMV infection with oral letermovir in Chinese R+ haplo-HSCT patients, as well as treatment-related mortality and all-cause mortality within 24 weeks after transplantation. For enrolled patients, Letermovir would be administered at a dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine). The regimen would start between +7\~+14d after transplantation. The total duration of dosing was approximately 100 days or 14 weeks.

Conditions

• The Incidence of Peripheral Blood CMV Activation and Confirmed Clinically Significant CMV Infection Within 24 Weeks After Transplantation

Interventions

Type	Name	Description
DRUG	Letermovir	For enrolled patients, Letermovir would be administered at a dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine). The regimen would start between +7\~+14d after transplantation. The total duration of dosing was approximately 100 days or 14 weeks.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-06-22
• Last updated: 2023-06-22

Regulatory

• FDA-regulated drug study