drugset
drugset / Trial / NCT05914675

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

NCT05914675 ↗

Phase 4 Unknown 21 enrolled Institute of Hematology & Blood Diseases Hospital, China
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-07-01
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Letermovir Small molecule 240 mg Oral
Subject Letermovir Small molecule 480 mg Oral

Indications

No indication recorded.