RECRUITING

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

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Conditions

Cytomegalovirus InfectionsInfection in Solid Organ Transplant RecipientsNeutropeniaAntiviral ToxicityCytomegalovirus infectionLetermovirSecondary prophylaxisT cell immunity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Trial of the Tolerability and Clinical Effectiveness of Letermovir When Used for Secondary Prophylaxis to Prevent Recurrent Cytomegalovirus Disease in Solid Organ Transplant Recipients

Quick Facts

Study Start:2023-02-02
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05626530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. Patient able to participate with follow up for 6 months
  3. 3. Not enrolled in competing clinical trials
  1. 1. Patients with creatinine clearance less than 10 ml per min at time of enrollment
  2. 2. Hypersensitivity to letermovir or has a CMV isolate which is known to be resistant to letermovir based on prior testing
  3. 3. On CVVH or renal dialysis at the time of enrollment
  4. 4. Has Child Pugh Class C severe hepatic insufficiency at screening.
  5. 5. Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency at screening.
  6. 6. 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.
  7. 7. 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.
  8. 8. Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
  9. 9. 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.
  10. 10. 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.
  11. 11. 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.
  12. 12. 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Jennifer K Chow, MD, MS
PRINCIPAL_INVESTIGATOR
Tufts Medical Center

Study Locations (Sites)

Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

  • Jennifer K Chow, MD, MS, PRINCIPAL_INVESTIGATOR, Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-02
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2023-02-02
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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