EUCTR2020-005996-11-GR进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 1,000 人开始时间: 2021年10月22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）
- 入组人数
- 1,000
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. Recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations, and meets 1 or more of the following criteria:
- •a) Early or Moderate Pre-term Group (excluding participants with CLD or hemodynamically significant CHD): =35 weeks, 0 days gestational age.
- •b) CLD/CHD Group:
- •- CLD Participants: have CLD of prematurity (also known as bronchopulmonary dysplasia), as defined by:
- •? American Academy of Pediatrics [American Academy of Pediatrics Committee on Infectious Diseases 2014]: =32 weeks, 0 days gestational age and require medical intervention/management for at least 28 days after birth, or
- •? Other national or local guidelines or professional society recommendations.
- •- CHD Participants: have hemodynamically significant CHD, as defined by:
- •? American Academy of Pediatrics [American Academy of Pediatrics
- •Committee on Infectious Diseases 2014]: Uncorrected or palliated cyanotic or acyanotic disease associated with documented pulmonary hypertension or a requirement for daily medication to manage congestive heart failure, or as diagnosed by a pediatric cardiologist
- •? other national or local guidelines or professional society recommendations.
- •2. Is available to complete the follow-up period:
- •- Up to 575 days (180 days after RSV Season 2 dose) for participants eligible for RSV Season 2 dose of MK-1654, or
- •- Approximately 365 days after the RSV Season 1 Dose 1 for all other participants.
- •3. Is male or female and has a chronological age from birth up to 1 year and is entering their first RSV season at the time informed consent is provided.
- •4. The participant’s legally acceptable representative provides documented informed consent for the study. The participant’s legally acceptable representative may also provide documented consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
- •For Participation in RSV Season 2:
- •5. Participants enrolled in the CLD/CHD group as defined in Inclusion Criteria #1b. Participants with CHD are required to meet the following additional criteria:
- •- Have hemodynamically significant CHD at the beginning of RSV Season 2, or
- •- If the participant has had surgically repaired hemodynamically significant CHD that did not include ECMO or cardiopulmonary bypass:
- •? Continues to require medications to manage CHD, or
- •? Any additional medical intervention related to their CHD
- •6. Participants enrolled in the Early or Moderate Pre-term Group as defined in Inclusion Criteria #1a, with the following conditions:
- •- Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough
- •- Down Syndrome (trisomy of chromosome 21)
- •- Cystic fibrosis with nutritional compromise (eg, weight <10th percentile at time of enrollment)
- •- Native Americans and Alaskan Indians
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •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. Requires mechanical ventilation at time of enrollment.
- •2. Has a life expectancy <6 months.
- •3. Has known hepatic or renal dysfunction, or chronic seizure disorder.
- •4. Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- •5. Has severe immunodeficiency or is severely immunocompromised, including but not limited to:
- •- AIDS (CD4 percentage <15%, or history of AIDS-Defining Condition),
- •- leukemia, myeloproliferative disorder, or other malignancy and receiving or expected to receive chemotherapy during the study,
- •- status post solid-organ or bone marrow transplantation and on a systemic immunosuppressive regimen,
- •- severe combined immunodeficiency.
- •6. Has known hypersensitivity to any component of MK-1654 or palivizumab.
- •7. Has received other investigational agents at any time before study entry.
- •8. Has a prior surgical correction of CHD or anticipated cardiac surgical procedure within 60 days of randomization resulting in hemodynamically insignificant CHD.
- •9. Requires ECMO or continuous positive airway pressure at the time of enrollment.
- •10. Has an anticipated or planned cardiac transplantation to occur during the course of this study.
- •11. Has a bleeding disorder contraindicating intramuscular administration.
- •12. Has had a recent illness with rectal temperature =100.5°F (=38.1°C) or axillary temperature =100.0°F (=37.8°C) within 72 hours predose.
- •13. Has symptoms of LRI within 7 days predose.
- •14. Has received any vaccine or mAb for the prevention of RSV, including receipt of maternal RSV vaccination during the mother’s pregnancy.
- •15. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor.
- •16. Has enrolled previously in the current study and been discontinued.
- •17. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
- •18. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
- •19. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
- •For Participation in RSV Season 2:
- •20. Has a life expectancy <6 months.
- •21. Has known hepatic or renal dysfunction, or chronic seizure disorder.
- •22. Has severe immunodeficiency or is severely immunocompromised, including but not limited to:
- •- AIDS (CD4 percentage <15%, or history of AIDS-Defining Condition),
- •- leukemia, myeloproliferative disorder, or other malignancy and receiving or expected to receive chemotherapy during the study,
- •- status post solid-organ or bone marrow transplantation and on a systemic immunosuppressive regimen,
- •- severe combined immunodeficiency.
- •23. Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.
- •24. Has known hypersensitivity to any component of MK-1654.
- •25. Has bleeding disorder contraindicating intramuscular administration.
- •26. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, ke
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