Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (… (NCT02137772) | Clinical Trial Compass
CompletedPhase 3
Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)
570 participantsStarted 2014-06-06
Plain-language summary
The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT). The hypothesis being tested was that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through Week 24 post-transplant.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant