NCT05914701

Secondary Prophylaxis of CMV Infection Using Letermovir After HID-HSCT

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of secondary prophylaxis of CMV reactivation, clinically significant CMV infection with oral letermovir in Chinese haplo-HSCT patients, as well as treatment-related mortality, all-cause mortality and QoL 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 duration of dosing was approximately 120 days or 16 weeks. Or physicians could adjust regimen duration according to the CMV infection risk factors.

Conditions

• To Evaluate the Efficacy and Safety of Secondary Prophylaxis of CMV Reactivation

Interventions

Type	Name	Description
DRUG	Letermovir for secondary prophylaxis	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 duration of dosing was approximately 120 days or 16 weeks. Or physicians could adjust regimen duration according to the CMV infection risk factors.

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