Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China (Soliris)
Atypical Hemolytic Uremic
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About this trial
This is an interventional treatment trial for Atypical Hemolytic Uremic focused on measuring atypical hemolytic uremic, aHUS
Eligibility Criteria
Inclusion Criteria: Any age weighing ≥ 5 kg Complement treatment naïve with evidence of TMA. History of aHUS prior to kidney transplant,or persistent evidence of TMA at least 4 days after modifying the immunosuppressive regimen. Among participants with onset of TMA postpartum, persistent evidence of TMA for > 3 days after the day of childbirth All participants must be vaccinated against N meningitidis if not already vaccinated within the time period of active coverage specified by the vaccine manufacturer. Participants < 18 years of age must have been vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to local vaccination schedule guidelines. In participants receiving treatment with medications known to cause TMA, persistent evidence of TMA at least 4 days after modifying the excluded medication Exclusion Criteria: Known familial or acquired ADAMTS13deficiency (activity < 5%). ST-HUS as demonstrated by local guidelines. Positive direct Coombs test which is indicative of a clinically significant immune-mediated hemolysis not due to aHUS. HIV infection, and /or unresolved meningococcal disease Ongoing sepsis, and / or presence or suspicion of active and untreated systemic infection Organ transplantation history, and/or Bone marrow transplant/hematopoietic stem cell transplant within 6 months prior to the start of Screening. Among participants with a kidney transplant, acute kidney dysfunction within 4 weeks of transplant consistent with the diagnosis of acute antibody-mediated rejection. Among participants without a kidney transplant, history of kidney disease other than aHUS Identified drug exposure-related HUS, and / or HUS related to vitamin B12 deficiency and / or known genetic defects of cobalamin C metabolism. History of malignancy within 5 years of Screening. Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome. Chronic dialysis. Prior use of complement inhibitors. Use of tranexamic acid within 7 days prior to the start of Screening. Other immunosuppressive therapies. Receiving chronic intravenous immunoglobulin (IVIg) within 8 weeks prior to the start of Screening. Received vasopressors or inotropes within 7 days prior to Screening. Previously or currently treated with a complement inhibitor. Has participated in another interventional treatment study or used any experimental therapy. Hypersensitivity to any excipient in eculizumab. Pregnant or breastfeeding.
Sites / Locations
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Arms of the Study
Arm 1
Experimental
Eculizumab
Participants will receive Eculizumab in a single dose vial.