JPRN-jRCT2071200070招募中3 期
A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Carein Pediatric Participants with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)
Yokosawa Jun0 个研究点目标入组 40 人开始时间: 2020年12月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 4weeks old 至 < 18age old（—）
- 性别
- All
入选标准
- •1. = or >28 days of age up to <18 years at the time of signing the informed consent.
- •2. Received HSCT within the past 12 months.
- •3. Diagnosis of TMA that persists for at least 72 hours despite initial management.
- •4. A TMA diagnosis based on meeting the select criteria during the Screening Period and/or = or <14 days prior to the Screening Period.
- •5. Body weight = or > 5 kilograms at Screening.
- •6. Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception.
- •7. Participants must be vaccinated against meningococcal infections if clinically feasible. Participants who cannot receive meningococcal vaccine should receive antibiotic prophylaxis.
- •8. Participants or their legally authorized representative must be capable of giving signed informed consent or assent.
排除标准
- •1. Thrombotic thrombocytopenic purpura (TTP) evidenced by ADAMTS13 deficiency.
- •2. Shiga toxin producing Escherichia coli infection.
- •3. Positive direct Coombs test
- •4. Clinical diagnosis of disseminated intravascular coagulation (DIC)
- •5. Known bone marrow/graft failure.
- •6. Diagnosis of veno-occlusive disease (VOD), regardless of severity.
- •7. Human immunodeficiency virus (HIV) infection
- •8. Unresolved meningococcal disease.
- •9. Presence or suspicion of sepsis (treated or untreated).
- •10. Pregnancy or breastfeeding.
- •11. Respiratory failure requiring mechanical ventilation
- •12. Previously or currently treated with a complement inhibitor
- •13. Participation in an interventional treatment study of any therapy for TMA
研究者
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