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)

• Status: Completed
• Trial end date: 2016-11-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Letermovir

Criteria

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