EUCTR2013-003831-31-BE进行中（未招募）1 期
A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients - MK-8228 vs. Placebo in Prevention of CMV infection in HSCT Recipients
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 540 人开始时间: 2014年4月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
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. be = 18 years of age on the day of signing informed consent.
- •2. have documented seropositivity for CMV (recipient CMV IgG seropositivity [R+]) within 1 year before HSCT.
- •3. be receiving a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
- •4. have undetectable CMV DNA (as confirmed by the central laboratory) from a plasma sample collected within 5 days prior to randomization.
- •5. be within 28 days post-HSCT at the time of randomization.
- •6. be highly unlikely to become pregnant or to impregnate a partner
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. received a previous allogeneic HSCT
- •2. has a history of CMV end-organ disease within 6 months prior to randomization.
- •3. has evidence of CMV viremia (if tested) at any time from either signing of the ICF or the HSCT procedure, whichever is earlier, until the time of randomization. (Note: Evidence of CMV viremia as reported by central lab will include reporting of test results as detectable, not quantifiable” or detected” with a numeric value provided.)
- •4. received within 7 days prior to screening or plans to receive during the study any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir (at doses > 3200 mg PO per day or > 25 mg/kg IV per day); valacyclovir (at doses > 3000 mg PO per day); famciclovir (at doses > 1500 mg PO per day)
- •5. received within 30 days prior to screening or plans to receive during the study any of the following: cidofovir; CMV hyper-immune globulin; Any investigational CMV antiviral agent/biologic therapy
- •6. has severe hepatic insufficiency within 5 days prior to randomization.
- •7. has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN within 5 days prior to randomization.
- •8. 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 5 days prior to randomization.
- •9. has an uncontrolled infection on the day of randomization.
- •10. requires mechanical ventilation or is hemodynamically unstable at the time of
- •randomization.
- •11. has previously participated 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.
研究者
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