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Letermovir for secondary prophylaxis for CMV disease in solid organ transplant recipients
| 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 |
| Therapeutic Area |
Cytomegalovirus Infection
|
| Principal Investigator |
David R. Snydman, MD |
| Min Age |
18 Years |
| Max Age |
75 Years |
| Gender |
Any |
| Contact |
David R. Snydman, MD
617-636-5788
dsnydman@tuftsmedicalcenter.org
|
| More Information |
https://clinicaltrials.gov/ct2/show/NCT05626530 |
Open label trial of letermovir for secondary prophylaxis for solid organ transplant recipients at risk of relapsing cytomegalovirus infection and disease
Inclusion Criteria
Solid organ transplant patient at risk for relapsing CMV infection or disease, written informed consent, not enrolled in another clinical trial
Exclusion Criteria
creatinine clearance < 10 cc
Study Requirements
This is an open label trial to assess the tolerability and clinical effectiveness of letermovir when used in preventing relapsing CMV disease and infection in solid organ transplant recipients. Patients who consent will receive letermovir instead of the usual cmv secondary prophylaxis of ganciclovir or valganciclovir. There are no extra visits or study related activites except for two extra blood draws. Patients will be followed as they are per usual care. The only other activity will be to maintain pill counts for adherence and to take calls to assure compliance with the therapy and assess tolerability. Individual patient follow up will be 6 months from the time of enrollent and the treatment period will be 8 weeks.
