Treatment for Heart Transplant Infection

Phase-Based Progress Estimates
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases, Boston, MAHeart Transplant Infection+4 More
18 - 70
All Sexes
What conditions do you have?

Study Summary

This trial will compare the rates of CMV infection and disease in 30 heart transplant patients who will be given letermovir as prophylaxis to a retrospective cohort of 374 heart transplant patients. The tolerability of letermovir will also be assessed.

Eligible Conditions
  • Heart Transplant Infection
  • Cytomegalovirus (CMV)
  • Neutropenia
  • Antiviral Toxicity

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1 year

1 year
Rate of CMV infection in letermovir recipients
Rate of opportunistic infections in letermovir arm compared to historic controls
Tolerability and Compliance of Letermovir
Use of GCSF in letermovir recipients compared to historic controls
12 months
Proportion of patients with neutropenia
Month 7
Measure of CMV specific T cell immunity in letermovir recipients compared to controls

Trial Safety

Trial Design

0 Treatment Group

35 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
240 Previous Clinical Trials
245,226 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,706 Previous Clinical Trials
4,964,022 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Is this an unprecedented research endeavor?

"To date, Merck Sharp & Dohme LLC has conducted 7 exploratory studies concerning this treatment. The initial trial was performed in 2019 and included 86 patients across 34 cities over 11 nations; Phase 2 drug approval followed shortly after its completion. Subsequent trials have been held since then." - Anonymous Online Contributor

Unverified Answer

Who might be most suited to participate in this medical trial?

"For this research, 35 people between 18-70 years old who have neutropenia must be enrolled. Additionally, prospective participants should not be a heart transplant recipient with CMV serostatus of both donor and recipient negative (CMV -/-), or currently taking part in another clinical trial." - Anonymous Online Contributor

Unverified Answer

What is the approximate size of the cohort involved in this clinical experiment?

"Yes, according to this trial is currently open for recruitment and was first announced on October 1st 2021. As of November 15th 2022 the study has yet to close off enrollment with 35 participants needed across two medical sites." - Anonymous Online Contributor

Unverified Answer

Has this therapeutic protocol been accorded the endorsement of the Food & Drug Administration?

"With Phase 4 data available, our team at Power has reasonably concluded that this treatment is safe and assigned it a score of 3." - Anonymous Online Contributor

Unverified Answer

Is this research open to senior citizens aged 75 and above?

"This medical study is seeking individuals aged between 18 years and 70 years." - Anonymous Online Contributor

Unverified Answer

What prior research has been conducted concerning this therapeutic approach?

"Currently, there are seven active trials investigating this specific treatment. None of these live clinical experiments have reached Phase 3 yet. Despite the majority of studies being located in Columbus, Ohio, 67 sites worldwide are collecting patient data on this promising therapy." - Anonymous Online Contributor

Unverified Answer

Are there any current openings in this clinical trial?

"Affirmative, according to's information this trial is presently recruiting patients. It was launched on October 1st 2021 and has been modified most recently on November 15th 2022. This research requires 35 willing participants between two sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.