Clinical trial NCT05763823: 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)
Official title: A Phase 3, Open Label, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) for the Prevention of Clinically Significant Cytomegalovirus (CMV) Infection in Chinese Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant
timeFrame: Up to Week 24 post-transplant (approximately 6 months)
Secondary outcomes:
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 16 weeks
measure: Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event
timeFrame: Up to 14 weeks
measure: Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant
timeFrame: Up to 14 weeks post-transplant (99 days)
measure: Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant
timeFrame: Up to 14 weeks post-transplant (99 days)
measure: Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant
timeFrame: Up to 24 weeks post-transplant (approximately 6 months)
measure: Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant
timeFrame: Up to 14 weeks post-transplant (99 days)
measure: Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant
timeFrame: Up to 24 weeks post-transplant (approximately 6 months)
measure: Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant
timeFrame: Up to 14 weeks post-transplant (99 days)
measure: Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant
timeFrame: Up to 24 weeks post-transplant (approximately 6 months)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 0024)
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital ( Site 0009)
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital-Hematology ( Site 0033)
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002)
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital of Third Military Medical University ( Site 0005)
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital Chongqing Medical University ( Site 0013)
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital-Hematology Department ( Site 0001)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 0003)
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital-Hematology Department ( Site 0006)
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028)
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 0032)
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University-hematology department ( Site 0029)
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College ( Site 0022)
state: Jiangsu
city: Nanchang
country: China
facility: The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0021)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University-Hematology ( Site 0023)
state: Jilin
city: Dalian
country: China
facility: The 2nd Affiliated Hospital of Dalian Medical University ( Site 0019)
state: Liaoning
city: Shanghai
country: China
facility: Shanghai General Hospital ( Site 0018)
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University ( Site 0008)
state: Sichuan
city: Chengdu
country: China
facility: The General Hospital of Western Theater Command ( Site 0007)
state: Sichuan
city: Tianjin
country: China
facility: Institute of hematology&blood disease hospital-Hematology ( Site 0030)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University ( Site 0025)
state: Zhejiang
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: