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

NCT05914675 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-06-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05914675 on ClinicalTrials.gov