Clareo Health | Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)
Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)
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Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
have documented positive CMV serostatus (CMV immunoglobulin G \[IgG\] seropositive) for recipient (R+) at the time of transplant
has a history of allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant) within \~100 days prior to randomization
has undetectable CMV deoxyribonucleic acid (DNA) or detectable/not quantifiable CMV DNA from a plasma sample collected within 14 days prior to randomization
has received LET as primary prophylaxis that started within 28 days of HSCT and continued through Week 14 post-transplant (± 1 week) prior to randomization
is at high risk of CMV disease, defined as meeting one or more of the following criteria:
has a related donor with at least 1 mismatch at 1 of the specified 3 human leukocyte antigen (HLA) gene loci (HLA-A, B, or DR)
has an unrelated donor with at least one mismatch at one of the specified four HLA gene loci (HLA-A, B, C, and DRB1)
has a haploidentical donor
has umbilical cord blood as the stem-cell source
has ex-vivo T-cell-depleted grafts
has received anti-thymocyte globulin
has received alemtuzumab
has graft versus host disease (GVHD) or other conditions, requiring the use of systemic prednisone (or equivalent) at a dose of ≥1 mg/kg of body weight per day within 6 weeks of randomization
for female participants, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOBCP who agrees to use acceptable contraception during the treatment period and for ≥28 days after the last dose of study drug.
You may not be if
has a history of CMV end-organ disease or preemptive treatment therapy for CMV after HSCT prior to randomization
has a history of \>14 days total of LET interruption during the first 100 days post-transplant prior to randomization
has suspected or known hypersensitivity to active or inactive ingredients of LET formulations
has severe hepatic insufficiency defined as Child-Pugh Class C within 14 days prior to randomization.
has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5× the upper limit of normal (ULN) within 14 days prior to randomization
has end-stage renal impairment with a creatinine clearance less than 10 mL/min, as calculated by the Cockcroft-Gault equation using serum creatinine within 14 days prior to randomization
has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency
has an uncontrolled infection on the day of enrollment
requires mechanical ventilation or is hemodynamically unstable at the time of enrollment
has a documented positive result for a human immunodeficiency virus antibody (HIV-Ab) test at any time prior to screening, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV ribonucleic acid (RNA), or hepatitis B surface antigen (HBsAg) within 6 months prior to screening.
has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (eg, lymphomas)
has received cidofovir or CMV immunoglobulin with 30 days prior to screening
is currently participating or has participated in a study with an unapproved investigational compound, monoclonal antibody, or device within 28 days or 5× half-life of the investigational compound or monoclonal antibody, whichever is longer, of initial dosing in this study
has previously participated in this study or any other study involving LET, or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study
is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 28 days after the last dose of study therapy
is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study therapy
has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol as assessed by the investigator
has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or would be put at undue risk as judged by the investigator, such that it is not in the best interest of the participant to participate in this study
