EUCTR2018-001038-17-IT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. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 216 人开始时间: 2021年1月22日最近更新:
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
- 性别
- All
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 week 14 post-transplant (100 days) ± 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 ex-vivo 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 28 days after the last dose of study medication.
- •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 screening, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within the 6 months prior to screening.
- •11. Participant has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer
- •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 28 days after the last dose of study therapy.
- •17. Participant is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study therapy.
- •18. Participant has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol as assessed by the investigator.
- •19. Participant has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or would be
研究者
相似试验
进行中（未招募）
1 期
Extension of LET from Day 100 to Day 200 post-transplant for the prevention of CMV infection in HSCT participantsCytomegalovirus (CMV) infectionMedDRA version: 20.1Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2018-001038-17-GBMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc216
进行中（未招募）
1 期
Extension of LET from Day 100 to Day 200 post-transplant for the prevention of CMV infection in HSCT participantsCytomegalovirus (CMV) infectionMedDRA version: 20.1 Level: PT Classification code 10011831 Term: Cytomegalovirus infection System Organ Class: 10021881 - Infections and infestationsEUCTR2018-001038-17-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc216
招募中
3 期
Phase 3 study of S-217622 in prevention of symptomatic SARS-CoV-2 infectioJPRN-jRCT2031230124Gomez Juan Carlos2,200
进行中（未招募）
1 期
Extension of LET from Day 100 to Day 200 post-transplant for the prevention of CMV infection in HSCT participantsCytomegalovirus (CMV) infectionMedDRA version: 20.1Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2018-001038-17-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc216
进行中（未招募）
不适用
Prevention of Borrelia infection and prevention of borreliosis through application of a gel, within three days, on the site of the tick biteEUCTR2011-000117-39-ATIxodes AG.3,300