Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

NCT05626530 | Recruiting Phase 4

• 1 other identifier: 00003219
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Cytomegalovirus infection; Letermovir; Secondary prophylaxis; T cell immunity; neutropenia

Outcome Measures

Primary Outcomes (1)

• Rate of Relapse after prophylaxis

  Proportion of patients with relapsing CMV disease up to 6 months after starting drug

  6 months after starting intervention

Secondary Outcomes (5)

• Opportunistic infection

  6 months after starting

• Adverse events associated with taking letermovir

  6 months after starting

• Neutropenia

  6 months after starting intervention

• Rejection

  6 months

• T cell function

  6 months after starting intervention

Study Arms (1)

single arm

OTHER

This is an open label single arm study

Drug: Letermovir

Interventions

Letermovir DRUG

Open label 480 mg given daily for 60 days

Also known as: Active drug

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\> 18 years old) solid organ transplant recipients (heart, kidney or liver patients) recovering from treated CMV disease in whom the clinician deems that the patient need secondary prophylaxis and in whom written informed consent is obtained.
• Patient able to participate with follow up for 6 months
• Not enrolled in competing clinical trials

You may not qualify if:

• Patients with creatinine clearance less than 10 ml per min at time of enrollment
• Hypersensitivity to letermovir or has a CMV isolate which is known to be resistant to letermovir based on prior testing
• On CVVH or renal dialysis at the time of enrollment
• Has Child Pugh Class C severe hepatic insufficiency at screening.
• Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency at screening.
• Note: Moderate hepatic insufficiency is defined as Child Pugh Class B (Appendix 8); moderate to severe renal insufficiency is defined as CrCl \<50 mL/min, as calculated by the Cockcroft-Gault equation.
• Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
• Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
• Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
• Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or put the participant at undue risk, as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.
• Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the 6 months) of drug or alcohol abuse or dependence.
• Note: Participants with a history of marijuana use which is not deemed excessive by an investigator or does not interfere with the participant's daily function may participate in the study.
• Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with an investigational monoclonal antibody will be eligible to participate after a 150-day washout period.
• Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent that is not approved or is planning to participate in a study of a CMV vaccine or another unapproved CMV investigational agent during the course of this study.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Neutropenia

Interventions

letermovir; Bulk Drugs

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Jennifer K Chow, MD, MS

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer K Chow, MD, MS

CONTACT

617-636-5244; Jennifer.Chow@TuftsMedicine.org

Whitney K Perry, MD, MS

CONTACT

339-368-0047; Whitney.Perry@tuftsMedicine.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label trial of letermovir given to eligible patients

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 2, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)