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New treatment option for Cytomegalovirus Infections
Official title Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients
ClinicalTrials.gov ID: NCT05626530
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cytomegalovirus infections.
Also referred to as Active drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult (\> 18 years old) solid organ transplant recipients (heart, kidney or liver patients) recovering from treated CMV disease in whom the clinician...
- Patient able to participate with follow up for 6 months
- Not enrolled in competing clinical trials
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- Patient able to participate with follow up for 6 months
- Not enrolled in competing clinical trials
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.