A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)

Merck Sharp & Dohme LLC120 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of a once-a-day oral or intravenous (IV) dose of Letermovir (MK-8228) in Chinese adult hematopoietic stem cell transplant (HSCT) recipients for the prevention of clinically significant cytomegalovirus (CMV) infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Cytomegalovirus Infection

Interventions

LetermovirDRUG

Daily 240 mg or 480 mg oral tablets or IV dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Male/Female Chinese adult participant of an allogeneic Hematopoietic Stem Cell Transplant (HSCT). * Has documented positive Cytomegalovirus (CMV) serostatus (CMV immunoglobulin G \[IgG\] seropositive) for recipient (R+) at the time of screening. * Is receiving a first allogeneic HSCT. * Is within 28 days post-HSCT at the time of randomization. * Female participant is not a Woman of Child Bearing 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. Exclusion Criteria: * Received a previous allogeneic HSCT. * Has a history of CMV end-organ disease within 6 months prior to randomization. * Has evidence of CMV viremia at any time from HSCT procedure until the time of randomization. * Has severe hepatic insufficiency. * Is a) on renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) OR b) has end stage renal impairment with a creatinine clearance \<=10 mL/min within 5 days prior to randomization. * Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency. * Has an uncontrolled infection on the day of randomization. * Has rapidly progressing disease that requires mechanical ventilation or is hemodynamically unstable. * Has a documented positive result for a human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV ribonucleic acid (RNA), or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization. * Has active solid tumor malignancies except localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas). * Has received any prohibited medications within 2 days prior to initiation of treatment with Letermovir. * Is anticipated to be treated with Traditional Chinese Medicine or herbal medicine during the study treatment period and for 14 days after study medication.

Locations (21)

Outcomes

Primary Outcomes

Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant

Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to week 24 post-transplant is reported.

Time frame: Up to Week 24 post-transplant (approximately 6 months)

Secondary Outcomes

Percentage of Participants Who Experienced an Adverse Event (AE)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.

Time frame: Up to 16 weeks

Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event

Time frame: Up to 14 weeks

Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant

Data from ClinicalTrials.gov

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Anhui Provincial Hospital ( Site 0024)

Hefei, Anhui, China

Peking University First Hospital ( Site 0009)

Beijing, Beijing Municipality, China

Peking University People's Hospital-Hematology ( Site 0033)

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002)

Chongqing, Chongqing Municipality, China

Southwest Hospital of Third Military Medical University ( Site 0005)

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital Chongqing Medical University ( Site 0013)

Chongqing, Chongqing Municipality, China

Guangzhou First People's Hospital-Hematology Department ( Site 0001)

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital ( Site 0003)

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital-Hematology Department ( Site 0006)

Shenzhen, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028)

Wuhan, Hubei, China

...and 11 more locations

Time frame: Up to 14 weeks post-transplant (99 days)

Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant

Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 14 weeks post-transplant is reported.

Time frame: Up to 14 weeks post-transplant (99 days)

Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant

Time frame: Up to 24 weeks post-transplant (approximately 6 months)

Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant

CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 14 weeks post-transplant is reported.

Time frame: Up to 14 weeks post-transplant (99 days)

Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant

Time frame: Up to 24 weeks post-transplant (approximately 6 months)

Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant

The percentage of participants who died due to any cause up to 14 weeks post-transplant is reported.

Time frame: Up to 14 weeks post-transplant (99 days)

Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant

The percentage of participants who died due to any cause up to 24 weeks post-transplant is reported.

Time frame: Up to 24 weeks post-transplant (approximately 6 months)