Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT05626530
Phase
PHASE4
Status
Recruiting
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Conditions

  • Antiviral Toxicity
  • Cytomegalovirus Infections
  • Infection in Solid Organ Transplant Recipients
  • Neutropenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Letermovir — DRUG
    Open label 480 mg given daily for 60 days

Study Details

This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient. This study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.

Key Dates

Start date
Feb 2, 2023
Status verified
Apr 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: single arm
    This is an open label single arm study

Primary Outcome Measure

Rate of Relapse after prophylaxis [ Time Frame: 6 months after starting intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical Center-Division of Geographic Medicine and Infectious DiseasesBostonMassachusetts02111
Jennifer K Chow, MD, MS
[email protected]
617-636-5244
Whitney Perry, MD, MS
[email protected]
339-368-0047
Jennifer K Chow, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases· Boston, MA

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