NL-OMON51930撤回3 期
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger - ALXN1210-TMA-315
PPD0 个研究点目标入组 4 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 4
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.18 years of age or older
- •2.Body weight >= 30 kilograms
- •3.Female participants of childbearing potential and male participants with
- •female partners of childbearing potential must use highly effective
- •contraception starting at screening and continuing until at least 8 months
- •after the last dose of ravulizumab
- •4.TMA (platelet count, LDH, and acute kidney injury) associated with a trigger
- •such as autoimmune, solid organ transplant or drug induced
- •5.Vaccinated against meningococcal infection (N meningitidis), within 3 years
- •prior to, or at the time of, randomization. Participants who initiate study
- •drug treatment less than 2 weeks after receiving a meningococcal vaccine must
- •receive appropriate prophylactic antibiotics for at least 2 weeks after the
- •vaccination. If participant cannot receive the meningococcal vaccine, then
- •participant must be willing to receive antibiotic prophylaxis coverage against
- •N meningitidis during the entire Treatment Period and for 8 months following
- •the final dose of study drug. Additional vaccination (Haemophilus influenzae
- •type b (Hib) and Streptococcus pneumoniae) may be considered based on
- •individual patient condition
排除标准
- •1.Any known gene mutation that causes aHUS
- •2.Postpartum aHUS
- •3.Known CKD
- •4.TMA due to hematopoietic stem cell transplantation <= 12 months of Screening
- •5.Primary and secondary glomerular diseases other than lupus
- •6.Diagnosis of primary antiphospholipid antibody syndrome
- •7.Known Shiga toxin-producing Escherichia coli infections including but not
- •limited to Shiga toxin-related hemolytic uremic syndrome
- •8.Known familial or acquired 'a disintegrin and metalloproteinase with a
- •thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity < 5%)
- •9.Positive direct Coombs test
- •10.Clinical diagnosis of disseminated intravascular coagulation (DIC)
- •11.Presence of sepsis
- •12.Presence of monoclonal gammopathy including but not limited to multiple
- •13.Known bone marrow insufficiency or failure evidenced by cytopenias
- •14.Unresolved N meningitidis infection
- •15.History of malignancy within 5 years of Screening with the exception of
- •nonmelanoma skin cancer or carcinoma in situ of the cervix that has been
- •treated with no evidence of recurrence
- •16.Use of any complement inhibitors within the past 3 years
研究者
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