Overview

This trial is active, not recruiting.

Condition cytomegalovirus infections
Treatments mk-8228, placebo
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2014
End date August 2016
Trial size 540 participants
Trial identifier NCT02137772, 152923, 2013-003831-31, 8228-001

Summary

The study will evaluate the efficacy and safety of MK-8228 for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant. The hypothesis being tested is that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through 24 weeks after transplant.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
MK-8228 oral or intravenous (IV) formulation will be administered once daily for up to 14 weeks after transplant. The dose will be 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion will be administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
mk-8228
(Placebo Comparator)
Placebo oral or IV formulation will be administered once daily for up to 14 weeks after transplant. The dose will be 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion will be administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
placebo

Primary Outcomes

Measure
Percentage of Participants with Clinically-Significant CMV Infection
time frame: Up to 24 weeks after transplant

Secondary Outcomes

Measure
Time to Onset of Clinically-Significant CMV Infection
time frame: Up to 24 weeks after transplant
Percentage of Participants with Clinically-Significant CMV Infection
time frame: Up to 14 weeks after transplant
Percentage of Participants with CMV Disease
time frame: Up to 14 weeks after transplant
Percentage of Participants with CMV Disease
time frame: Up to 24 weeks after transplant
Percentage of Participants with Pre-emptive Therapy for CMV Viremia
time frame: Up to 14 weeks after transplant
Percentage of Participants with Pre-emptive Therapy for CMV Viremia
time frame: Up to 24 weeks after transplant
Time to Initiation of Pre-emptive Therapy for CMV Viremia
time frame: Up to 24 weeks after transplant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..