Experimental Medicine Letermovir To Prevent Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

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"This study will help determine whether an experimental drug, letermovir, is a safe and effective to prevent CMV infections."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Human Cytomegalovirus Disease, CMV
Type: Drug study, Phase 3
Target:
8 Participants
Investigator:
Description
CMV commonly infects humans. In the US, it’s estimated that 50-80% of the population has been infected with CMV by 40 years of age. While common, CMV infection is usually asymptomatic or has mild symptoms in healthy adults. However, serious disease occurs almost entirely in individuals who are immunocompromised. For example, in kidney transplant patients.

There is currently no cure or vaccine for CMV. In order to prevent CMV infections, this study will help determine whether an experimental drug, letermovir, is a safe and effective preventative treatment for transplant recipients. We want to know if there are any unwanted effects on your health related to the use of letermovir.

In this study, letermovir will be compared to a current FDA approved drug, valganciclovir, to prevent CMV infections. In addition, you may receive acyclovir to prevent other viral infections. Letermovir has been approved in the USA and other countries for use in certain transplant patients. It may not be approved for your type of transplant.
This study requires

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.

Who can participate

Inclusion criteria:

  • Has documented seropositivity for CMV within 1 year before hematopoietic stem cell transplant (HSCT)
  • Receiving first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant)
  • Female or male participant who is not of reproductive potential, or, if of reproductive potential, agrees to true abstinence or to use (or have their partner use) 2 acceptable methods of birth control from the time of consent through 90 days after the last dose of study drug
  • Able to read, understand, and complete questionnaires and diaries

Exclusion criteria:

  • Received a previous allogeneic HSCT (previous autologous HSCT is acceptable)
  • History of CMV end-organ disease within 6 months before randomization
  • Has evidence of CMV viremia (if tested) at any time from either signing of the Informed Consent Form or the HSCT procedure, whichever is earlier, until the time of randomization.
  • Received the following within 7 days before screening or plans to receive during the study: ganciclovir, valganciclovir, foscarnet, acyclovir, valacyclovir, or famciclovir
  • Received the following within 30 days before screening or plan to receive during the study: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent or biological therapy
  • Has suspected or known hypersensitivity to ingredients of MK-8228 (letermovir) formulations
  • Has severe hepatic insufficiency within 5 days before randomization
  • Has end-stage renal impairment
  • Has an uncontrolled infection on the day of randomization
  • Requires mechanical ventilation or is hemodynamically unstable at the time of randomization
  • Has documented positive results for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody with detectable HCV ribonucleic acid, or hepatitis B surface antigen (HBsAg) within 90 days before randomization
  • Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (for example, lymphoma)
  • Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of study drug
  • Is expecting to donate eggs or sperm from the time of consent through 90 days after the last dose of study drug
  • Has participated in a study with an unapproved investigational compound (monoclonal antibodies are excepted) or device within 28 days of the first dose of study drug
  • Has previously participated in a MK-8228 (letermovir) study
  • Has, is, or is planning (during the study) to participate in any study involving administration of a CMV vaccine or another CMV investigational agent
  • Is a user of recreational or illicit drugs or has a recent history (<=1 year) of drug or alcohol abuse or dependence
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $50 per visit for your time and effort. In addition you will receive $10 for completion of the study drug diary at each visit. If you participate in the optional intensive PK, you will also receive $210.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for about 54 weeks.
Recruitment period
From March 27, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Kate Trigg
Research Topic
Conditions:
  • Prevention of CMV Infection or Disease