EUCTR2018-001326-25-DE进行中（未招募）1 期
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 Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 65 人开始时间: 2019年2月7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
- 65
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.
- •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
- •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
- •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.
- •20. Is pregnant or expecting to conceive, is breastfeeding, or plans to
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