Cytomegalovirus InfectionsPhase 4NCT05626530
Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients
A Phase 4 study testing Letermovir in people with Cytomegalovirus Infections and Infection in Solid Organ Transplant Recipients, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cytomegalovirus Infections, Infection in Solid Organ Transplant Recipients, Neutropenia
- What is being tested?
- Letermovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, 02111
About this study
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
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.
Read the detailed description
This study will enroll solid organ transplant recipients who develop cytomegalovirus infection and disease who have been treated. At the time of finishing treatment, if the clinician feels that secondary prophylaxis is indicated, they will be enrolled to receive Letermovir 480 mg orally once a day for 60 days. CMV specific T cell assays will be obtained at the initiation of secondary prophylaxis and at the discontinuation of secondary prophylaxis. Patients will be followed for 4 months following discontinuation of secondary prophylaxis to see if they relapse.
- Conditions
- Cytomegalovirus Infections, Infection in Solid Organ Transplant Recipients, Neutropenia, Antiviral Toxicity
- Being tested
- Letermovir
- Keywords
- Cytomegalovirus infection, Letermovir, Secondary prophylaxis, T cell immunity, neutropenia
- Medical subject headings
- Cytomegalovirus Infections, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Also called Active drug
Open label 480 mg given daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | This is an open label single arm study Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Relapse after prophylaxis
Proportion of patients with relapsing CMV disease up to 6 months after starting drug
Measured: 6 months after starting intervention
Secondary outcomes (5)
Opportunistic infection
Rate of opportunistic infections or other infectious outcomes in the letermovir arm.
Measured: 6 months after starting
Adverse events associated with taking letermovir
Tolerability and compliance of patients taking letermovir in terms of adverse events
Measured: 6 months after starting
Neutropenia
Duration and nadir of neutropenia in the letermovir group
Measured: 6 months after starting intervention
Rejection
Rate of rejection at 6 months after starting secondary prophylaxis in the letermovir arm.
Measured: 6 months
T cell function
Proportion of patients who have demonstrated CMV specific T cell immunity at start of letermovir secondary prophylaxis will be compared to the proportion who have CMV specific T cell function at the discontinuation of prophylaxis
Measured: 6 months after starting intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start2 Feb 2023
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label trial of letermovir given to eligible patients
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer K Chow, MD, MS, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626530
- Sponsor's protocol ID
- 00003219
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05626530
- Acronym / sponsor ID
- 00003219
- Conditions
- Cytomegalovirus Infections, Infection in Solid Organ Transplant Recipients, Neutropenia, Antiviral Toxicity
- Keywords
- Cytomegalovirus infection, Letermovir, Secondary prophylaxis, T cell immunity, neutropenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll solid organ transplant recipients who develop cytomegalovirus infection and disease who have been treated. At the time of finishing treatment, if the clinician feels that secondary prophylaxis is indicated, they will be enrolled to receive Letermovir 480 mg orally once a day for 60 days. CMV specific T cell assays will be obtained at the initiation of secondary prophylaxis and at the discontinuation of secondary prophylaxis. Patients will be followed for 4 months following discontinuation of secondary prophylaxis to see if they relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label trial of letermovir given to eligible patients
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Drug: LetermovirThis is an open label single arm study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirAlso: Active drugOpen label 480 mg given daily for 60 days | Drug | single arm |
Primary outcome
Rate of Relapse after prophylaxis
Time frame: 6 months after starting intervention
Proportion of patients with relapsing CMV disease up to 6 months after starting drug
5 secondary outcomes
Opportunistic infection
Time frame: 6 months after starting
Adverse events associated with taking letermovir
Time frame: 6 months after starting
Neutropenia
Time frame: 6 months after starting intervention
Rejection
Time frame: 6 months
T cell function
Time frame: 6 months after starting intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer K Chow, MD, MS principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letermovir in people with Cytomegalovirus Infections and Infection in Solid Organ Transplant Recipients, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Relapse after prophylaxis (time frame: 6 months after starting intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.