跳至主要内容
临床试验/NCT05763823
NCT05763823已完成3 期

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

Merck Sharp & Dohme LLC21 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年3月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
21
主要终点
Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Letermovir

Experimental

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.

干预措施: Letermovir (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Percentage of Participants Who Experienced an Adverse Event (AE)(Up to 16 weeks)
  • Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event(Up to 14 weeks)
  • Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
  • Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
  • Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant(Up to 24 weeks post-transplant (approximately 6 months))
  • Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
  • Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant(Up to 24 weeks post-transplant (approximately 6 months))
  • Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
  • Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant(Up to 24 weeks post-transplant (approximately 6 months))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (21)

Loading locations...

相似试验