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)
- Registration Number
- NCT05763823
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Letermovir Letermovir Chinese HSCT recipients will receive 240 mg of Letermovir \[for participants on Cyclosporin A (CsA)\] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (\~100 days) post-transplant.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant Up to Week 24 post-transplant (approximately 6 months) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experienced an Adverse Event (AE) Up to 16 weeks 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.
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event Up to 14 weeks 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 discontinued study treatment due to an AE is reported.
Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant Up to 14 weeks post-transplant (99 days) 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 14 weeks post-transplant is reported.
Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant Up to 14 weeks post-transplant (99 days) 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.
Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant Up to 24 weeks post-transplant (approximately 6 months) 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 24 weeks post-transplant is reported.
Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant Up to 14 weeks post-transplant (99 days) 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.
Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant Up to 24 weeks post-transplant (approximately 6 months) 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 24 weeks post-transplant is reported.
Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant Up to 14 weeks post-transplant (99 days) The percentage of participants who died due to any cause up to 14 weeks post-transplant is reported.
Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant Up to 24 weeks post-transplant (approximately 6 months) The percentage of participants who died due to any cause up to 24 weeks post-transplant is reported.
Trial Locations
- Locations (21)
Institute of hematology&blood disease hospital-Hematology ( Site 0030)
🇨🇳Tianjin, Tianjin, China
Shenzhen Second People's Hospital-Hematology Department ( Site 0006)
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital of Soochow University-hematology department ( Site 0029)
🇨🇳Suzhou, Jiangsu, China
The First Hospital of Jilin University-Hematology ( Site 0023)
🇨🇳Changchun, Jilin, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0021)
🇨🇳Nanchang, Jiangxi, China
The General Hospital of Western Theater Command ( Site 0007)
🇨🇳Chengdu, Sichuan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0032)
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical College ( Site 0022)
🇨🇳Xuzhou, Jiangsu, China
The 2nd Affiliated Hospital of Dalian Medical University ( Site 0019)
🇨🇳Dalian, Liaoning, China
Shanghai General Hospital ( Site 0018)
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University ( Site 0008)
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University ( Site 0025)
🇨🇳Hangzhou, Zhejiang, China
Anhui Provincial Hospital ( Site 0024)
🇨🇳Hefei, Anhui, China
Peking University People's Hospital-Hematology ( Site 0033)
🇨🇳Beijing, Beijing, China
Peking University First Hospital ( Site 0009)
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002)
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital Chongqing Medical University ( Site 0013)
🇨🇳Chongqing, Chongqing, China
Southwest Hospital of Third Military Medical University ( Site 0005)
🇨🇳Chongqing, Chongqing, China
Guangzhou First People's Hospital-Hematology Department ( Site 0001)
🇨🇳Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0003)
🇨🇳Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028)
🇨🇳Wuhan, Hubei, China