Trials / Completed
CompletedNCT04017962
A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection
An Open-label, Single-arm Study of Letermovir (LTV) for Prevention of Recurrent CMV Infection in High-risk Hematopoietic Cell Transplant (HCT) Recipients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Letermovir Pill | Patients enrolled on the study will receive oral LTV 480 mg daily (240 mg daily for patients receiving cyclosporine A). The maximum duration of LTV administration will be 14 weeks. Patients receiving oral medication will be administered a pill diary for drug compliance purposes. This will be administered and reconciled in clinic. |
| OTHER | blood draw | Collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180. |
Timeline
- Start date
- 2019-07-19
- Primary completion
- 2024-08-07
- Completion
- 2025-07-29
- First posted
- 2019-07-12
- Last updated
- 2025-08-11
- Results posted
- 2025-07-30
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04017962. Inclusion in this directory is not an endorsement.