Actively Recruiting
Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients
Led by Tufts Medical Center · Updated on 2025-04-10
25
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult solid organ transplant recipients (heart, kidney, or liver) over 18 years old recovering from treated CMV disease and deemed to need secondary prophylaxis
- Able to participate with follow-up for 6 months
- Not enrolled in competing clinical trials
You will not qualify if you...
- Creatinine clearance less than 10 ml per minute at enrollment
- Hypersensitivity to Letermovir or known resistance to Letermovir
- Receiving continuous venovenous hemofiltration (CVVH) or renal dialysis at enrollment
- Severe liver failure classified as Child Pugh Class C
- Both moderate liver insufficiency (Child Pugh Class B) and moderate to severe kidney insufficiency (CrCl less than 50 mL/min)
- History of malignancy within 5 years except certain treated skin or cervical cancers
- Pregnant, breastfeeding, or planning pregnancy or breastfeeding through 90 days after study therapy
- Planning to donate eggs or sperm during the study and 90 days afterward
- Any condition, therapy, lab abnormality, or circumstance interfering with study participation or safety as judged by the investigator
- Use of recreational or illicit drugs or recent history of drug or alcohol abuse within 6 months
- Participation in other investigational drug or device studies within 28 days or 5 half-lives (excluding monoclonal antibodies), or within 150 days if previously treated with investigational monoclonal antibodies
- Current or planned participation in studies involving CMV vaccines or unapproved CMV agents during this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, United States, 02111
Actively Recruiting
Research Team
J
Jennifer K Chow, MD, MS
CONTACT
W
Whitney K Perry, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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