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)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-06

Study Completion Date

2016-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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)

NCT03930615

Cytomegalovirus Infection

COMPLETED PHASE3

Letermovir for the Prevention of CMV Infection in HSCT Recipients Based on the Outcome of mNGS

NCT06021210

CMV Infection Hematopoietic Stem Cell Transplantation

UNKNOWN PHASE2

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

NCT04129398

Cytomegalovirus Infection Cytomegalovirus Disease

COMPLETED PHASE3

A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection

NCT04017962

CMV CMV Infection Hematopoietic Cell Transplant

COMPLETED PHASE2

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

NCT03940586

Cytomegalovirus (CMV) Infection

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention of CMV Infection or Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Letermovir

Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.

Group Type EXPERIMENTAL

Letermovir

Intervention Type DRUG

Letermovir 240 mg / 480 mg tablets, or 240 mg / 480 mg intravenous solution in 250 mL to be infused over 60 minutes.

Placebo

Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Letermovir

Letermovir 240 mg / 480 mg tablets, or 240 mg / 480 mg intravenous solution in 250 mL to be infused over 60 minutes.

Intervention Type DRUG

Placebo

Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-8228

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No