|Age:||18 years or older|
|Keywords:||Human Cytomegalovirus Disease, CMV|
|Type:||Drug study, Phase 3|
Before any study-related tests and procedures are performed, you will be asked to read and sign a consent document.
You will have to undergo testing (screening period) to determine if you meet the entrance requirements for the study. The screening period can last up to 14 days.
If you meet the study requirements, you will be assigned to one of the study drug groups, letermovir or valganciclovir. You will continue study assigned drug(s) for a period of up to 28 weeks (treatment period).
At each of the study visits, the study doctor or staff may do any or all of the following:
Give you the study drug and describe how to take it
You will receive a Participant Identification Card. This pocket card is intended for health care professionals and contains important information about this study as well as contact information to be used in case of an emergency. Please carry this card with you all the time and show it whenever you consult a health care professional
Assess you for CMV disease
Review your health history, including details of your transplant, and ask how you are feeling
Review prior and current medications you are taking Review your study medication diary
Conduct a physical exam including vital signs
Perform electrocardiograms (ECG) to check the electrical activity of your heart
Check your kidney and liver functions
You will be asked to complete electronic questionnaires to measure your health and well-being
Collect blood and urine samples
Collect blood for pharmacokinetic (PK) testing (to determine the way your body absorbs, distributes, and gets rid of the study medication): o For required PK testing at the Week 1 visit (if you are of Asian descent), you may require an overnight stay at the study site or local facility. You may have an IV saline lock placed at the study site to alleviate the number of venipunctures, this will be removed when you leave the study site. o For required PK testing (if you receive more than 5 consecutive days of IV study drug), you may require an overnight stay at the study site or local facility. o For OPTIONAL PK testing (if you are not of Asian descent). You may be asked to make a selection at the end of this document if you qualify and choose to have these samples drawn.