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Pit of 100 trials extended
Pit of 100 trials extended












pit of 100 trials extended

  • has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5× the upper limit of normal (ULN) within 14 days prior to randomization.
  • has severe hepatic insufficiency defined as Child-Pugh Class C within 14 days prior to randomization.
  • has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
  • has a history of >14 days total of LET interruption during the first 100 days post-transplant prior to randomization.
  • has a history of CMV end-organ disease or preemptive treatment therapy for CMV after HSCT prior to 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.
  • 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.
  • has umbilical cord blood as the stem-cell source.
  • 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 related donor with at least 1 mismatch at 1 of the specified 3 human leukocyte antigen (HLA) gene loci (HLA-A, B, or DR).
  • is at high risk of CMV disease, defined as meeting one or more of the following criteria:.
  • 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.
  • has undetectable CMV deoxyribonucleic acid (DNA) or detectable/not quantifiable CMV DNA from a plasma sample collected within 14 days prior to randomization.
  • has a history of allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant) within ~100 days prior to randomization.
  • have documented positive CMV serostatus (CMV immunoglobulin G seropositive) for recipient (R+) at the time of transplant.
  • pit of 100 trials extended

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    Pit of 100 trials extended