EUCTR2020-000144-61-DE进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT) - Ravulizumab in TMA after HSCT
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
- 114
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
- •1.12 years of age or older, at the time of signing the informed consent form (ICF)
- •2.participants who received HSCT within the past 12 months at the time of Screening
- •3.A TMA diagnosis, based on meeting all of the following criteria during the Screening Period and/or = 14 days prior to the Screening Period:
- •De novo thrombocytopenia
- •Any one of the following markers of hemolysis
- •- LDH > ULN for age
- •- Presence of schistocytes = 2 high power field (HPF) or = 1% in peripheral blood smear
- •Proteinuria on spot urinalysis
- •De novo anemia OR the presence of hypertension
- •4.Participants must have HSCT-TMA that persists despite initial management of any triggering condition (persists for at least 72 hours after management of triggering agent/condition)
- •Withdrawal or dose reduction of the offending agent (eg, CNIs)
- •Treatment of any underlying infection
- •Treatment of underlying GVHD
- •5.Body weight = 30 kg at Screening or = 7 days prior to the start of the
- •Screening Period (date of consent).
- •6. Participants must be vaccinated against meningococcal infections if clinically feasible, according to institutional guidelines for immune reconstitution after HSCT. Participants < 18 years of age must be revaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae if clinically feasible, according to institutional guidelines for immune reconstitution after HSCT. All participants should be administered coverage with prophylactic antibiotics according to institutional posttransplant infection prophylaxis guidances including coverage against N. meningiditis for at least 2 weeks after
- •meningococcal vaccination. Participants who cannot receive meningococcal vaccine should receive antibiotic prophylaxis coverage against N. meningiditis the entire Treatment Period and for 8 months
- •following the final dose of ravulizumab
- •7.Male or female
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •8.Capable of giving signed informed consent or assent which includes compliance with the requirements and restrictions listed in the informed consent and in this protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Known familial or acquired ‘a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13’ (ADAMTS13) deficiency (activity < 5%) .
- •2.Known Shiga toxin-related hemolytic uremic syndrome (ST-HUS)
- •3.Positive direct Coombs test result
- •4.Clinical diagnosis or suspicion 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 (evidenced by HIV-1 or HIV-2 antibody titer,
- •8.Unresolved meningococcal disease
- •9.Presence or suspicion of sepsis (treated or untreated) within 7 days prior to Screening
- •10.Pregnancy or breastfeeding
- •11.Hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab
- •12. Any ongoing or history of medical or psychological conditions unrelated to HSCT-TMA that, could increase the risk to the participant by participating in the study or confound the outcome of the study. Including but not limited to, major cardiac, pulmonary, renal, endocrine, or hepatic disease
- •13.Previously or currently treated with a complement inhibitor
研究者
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