A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of CMV Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)
Cytomegalovirus Infection
About this trial
This is an interventional prevention trial for Cytomegalovirus 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.
Sites / Locations
- Anhui Provincial Hospital ( Site 0024)Recruiting
- Peking University First Hospital ( Site 0009)Recruiting
- Peking University People's Hospital-Hematology ( Site 0033)Recruiting
- The Second Affiliated Hospital Chongqing Medical University ( Site 0013)Recruiting
- The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002)Recruiting
- Southwest Hospital of Third Military Medical University ( Site 0005)Recruiting
- Guangzhou First People's Hospital-Hematology Department ( Site 0001)Recruiting
- Southern Medical University Nanfang Hospital ( Site 0003)Recruiting
- Shenzhen Second People's Hospital-Hematology Department ( Site 0006)Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028)Recruiting
- Tongji Hospital Tongji Medical,Science & Technology ( Site 0032)Recruiting
- The First Affiliated Hospital of Soochow University-hematology department ( Site 0029)Recruiting
- The Affiliated Hospital of Xuzhou Medical College ( Site 0022)Recruiting
- The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0021)Recruiting
- The First Hospital of Jilin University-Hematology ( Site 0023)Recruiting
- The 2nd Affiliated Hospital of Dalian Medical University ( Site 0019)Recruiting
- Shanghai General Hospital ( Site 0018)Recruiting
- West China Hospital, Sichuan University ( Site 0008)Recruiting
- The General Hospital of Western Theater Command ( Site 0007)Recruiting
- Institute of hematology&blood disease hospital-Hematology ( Site 0030)Recruiting
- The First Affiliated Hospital, Zhejiang University ( Site 0025)Recruiting
Arms of the Study
Arm 1
Experimental
Letermovir
Chinese HSCT recipients will receive 240 mg [for participants on Cyclosporin A (CsA)] or 480 mg (for participants not on CsA) Letermovir orally or IV once daily through week 14 (~100 days) post-transplant.