EUCTR2018-001038-17-FR进行中（未招募）1 期
A Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of letermovir (LET) prophylaxis when extended from 100 days to 200 days post transplant in cytomegalovirus (CMV) seropositive recipients (R+) of an allogenic hematopoietic stem cell transplant (HSCT)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 216 人开始时间: 2019年2月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Participant has documented positive CMV serostatus (CMV IgG seropositive) for recipient (R+) at the time of transplant.
- •2. Participat has history of allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant) within ~100 days prior to randomization.
- •3.Participant has undetectable CMV DNA or detectable/not quantifiable CMV DNA (central laboratory) from a plasma sample collected within 14 days prior to randomization.
- •4. Participant has received LET as primary prophylaxis that started within 28 days of HSCT and continued through 14 weeks post-transplant (± 1 week) prior to randomization.
- •5.Participant is at high risk of CMV disease, defined as meeting one or more of the following criteria:
- •a. having a related donor with at least one mismatch at one of the specified three HLA gene loci (HLA-A, B, or DR);
- •b. having an unrelated donor with at least one mismatch at one of the specified four HLA gene loci (HLA-A, B, C, and DRB1);
- •c. having a haploidentical donor;
- •d. having umbilical cord blood as the stem-cell source;
- •e. having T-cell–depleted grafts;
- •f. receipt of anti-thymocyte globulin;
- •g. receipt of alemtuzumab;
- •h. having GVHD or other conditions, requiring the use of systemic prednisone (or equivalent) at a dose of =1 mg/kg of body weight per day within 6 weeks of randomization.
- •Demographics
- •6. Participant is =18 years of age at the time of signing the informed consent.
- •Female Participants
- •7. A female participant is eligible to participate if she is not pregnant (Appendix 5), not breastfeeding, and at least 1 of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5.
- •b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during thetreatment period and for at least 90 days after the last dose of study intervention.
- •Informed Consent
- •8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Medical Conditions
- •1. Participant has a history of CMV end-organ disease or preemptive treatment therapy for CMV after HSCT prior to randomization.
- •2. Participant has a history of >14 days total of LET interruption during the first 100 days post-transplant prior to randomization
- •3.Participant has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
- •4. Participant has severe hepatic insufficiency defined as Child-Pugh Class C within 14 days prior to randomization.
- •5. Participant has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5× the upper limit of normal (ULN) within 14 days prior to randomization.
- •6. Participant has end-stage renal impairment with a creatinine clearance less than 10 mL/min, as calculated by the Cockcroft-Gault equation using serum creatinine within 14 days prior to randomization
- •7. Participant has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency.
- •8. Participant has an uncontrolled infection on the day of enrollment.
- •9. Participant requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
- •10. Participant has a documented positive result for an human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
- •11. Participant has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (eg, lymphomas)
- •Prior/Concomitant Therapy
- •12. Received within 7 days prior to screening any of the following:
- •- ganciclovir or valganciclovir
- •- foscarnet
- •- acyclovir (at doses greater than those recommended for HSV/VZV prophylaxis;
- •- valacyclovir (at doses greater than those recommended for HSV/VZV prophylaxis;
- •- famciclovir (at doses greater than those recommended for HSV/VZV prophylaxis;
- •13. Participant received within 30 days prior to screening any of the following:
- •- cidofovir
- •- CMV immunoglobulin
- •Prior/Concurrent Clinical Study Experience
- •14. Participant is currently participating or has participated in a study with an unapproved investigational compound, monoclonal antibody, or device within 28 days or 5× half-life of the investigational compound or monoclonal antibody, whichever is longer, of initial dosing in this study.
- •15. Participant has previously participated in this study or any other study involving LET, or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
- •Other Exclusions
- •16. Participant is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of study therapy.
- •17. Participant is expecting to donate eggs or sperm starting from the time of
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