A Phase 2b open-label, single-arm study to evaluate pharmacokinetics, efficacy, safety and tolerability of letermovir in pediatric participants from birth to less than 18 years of age at risk of developing CMV infection and/or disease following allogeneic haematopoietic stem cell transplantation (HSCT)Updated PIP decision number: P/0362/2019

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc0 个研究点目标入组 60 人开始时间: 2022年2月11日最近更新: 2023年10月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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. All Age Group 1 participants must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+) within 90 days prior to enrollment. Participants in Age Group 2 and 3 must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+) within 90 days prior to enrollment and/or for the donor (D+); the donor serostatus should be documented within 1 year prior to enrollment.
•2. Be the recipient of a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
•3. Have undetectable CMV DNA from a plasma or whole blood sample collected within 5 days prior to enrollment.
•4. Be within 28 days post-HSCT at the time of enrollment.
•5. Participant is aged from birth to <18 years of age at the time of signing the informed consent/assent.
•6. 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 the protocol.
•b. A WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 28 days after the last dose of study intervention.
•7. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant or legally acceptable representative may also provide consent/assent for FBR. However, the participant may participate in the study without participating in FBR.
•8. Study participants in Panel A of Age Groups 1 and 2 must not be on concomitant CsA and must be able to take (as assessed by the investigator) LET tablets or the oral granules (either by mouth or via G tube/NG tube), provided the participant does not have a condition that may interfere with the absorption of oral medication (eg, vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment until the intensive PK sampling is completed in these panels (Day 7 Visit).
•9. For Age Group 2, the participant’s weight should be at least 10 kg; and for Age Group 3, the participant’s weight should be at least 2.5 kg and less than or equal to 15 kg at the time of enrollment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Received a previous allogeneic HSCT (Receipt of a previous autologous HSCT acceptable).
•2. History of CMV end-organ disease within 6 months prior to enrollment.
•3. Evidence of CMV viremia at any time from either signing of ICF or HSCT procedure, whichever is earlier, until time of enrollment.
•4. Suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
•5. Severe hepatic insufficiency (defined as Child-Pugh Class C) within 5 days prior to enrollment.
•6. 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 enrollment.
•7. Is a) on renal replacement therapy (eg, hemodialysis, peritoneal dialysis)
•b) has end-stage renal impairment with a creatinine clearance =10 mL/min, as calculated by the Cockcroft-Gault equation (for participants =12 years of age) or =10 mL/min/1.73 m2 by the modified Schwartz equation (for participants <12 years of age) using serum creatinine within 5 days prior to enrollment.
•8. Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency.
•9. Uncontrolled infection on the day of enrollment.
•10. Requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
•11. Has a documented positive result for a HIVAb test at any time prior to enrollment, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
•12. Active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (eg, lymphomas).
•13. Preexisting cardiac condition a) for which the patient is currently being treated or b) which required hospitalization within the last 6 months or c) that may be expected to recur during the course of the trial. Examples of preexisting cardiac conditions that would preclude enrollment include atrial fibrillation and atrial flutter.
•14. Received within 7 days prior to enrollment any of the following - ganciclovir, 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
•15. Received within 30 days prior to enrollment of any of the following:
•- cidofovir
•- CMV immunoglobulin
•- any investigational CMV antiviral agent/biologic therapy
•- Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John’s wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil and bosentan.
•16. Received letermovir at any time prior to enrollment in this study.
•17. Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing in this study. Participants previously treated with a monoclonal antibody will be eligible to participate after a 28-day washout period.
•18. Previously participated in this study or any other study involving LET.
•19. 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

发起方

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc

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