Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UWMSN | SMPH | Surgery - Trans | Other Identifier | UW Madison | |
| Protocol Version 3/12/26 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.
Participants will take letermovir for 84 days.
This study is being done to see if letermovir prevents CMV reactivation in seropositive participants with a kidney or liver transplant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive letermovir | Experimental | Participants will take letermovir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letermovir | Drug | 1 tablet by mouth, once daily, for 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of letermovir as a prophylaxis of CMV | Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load >1000 IU/mL. | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity | To be measured using the Eurofins-Viracor CMV inSIGHT™ T Cell Immunity testing. The test measures the strength of T cell responses to Cytomegalovirus (CMV) specific antigens. | 84 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Office of Clinical Research Department of Surgery | Contact | 608-576-0788 | surgeryresearch@surgery.wisc.edu | |
| Margaret R Jorgenson, PharmD | Contact | mjorgenson@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| David Al-Adra, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000588473 | letermovir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided