[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491824":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":31,"collaborators":24,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":24,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":24,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":24},{"fullName":5,"class":6},"NovelMed Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","6 subjects will receive an intravenous (IV) infusion of NM8074 at every two weeks for a total of 7 doses",[13],"Drug: NM8074",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","6 subjects will receive weekly doses of 10 mg\u002Fkg for a total of 4 doses followed by biweekly doses at 20 mg\u002Fkg for a total of 5 doses",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","NM8074","NM8074 will be administered as an intravenous infusion. In Cohort 1, all subjects will be administered 20 mg\u002Fkg of NM8074 intravenously every two weeks for a total of 7 doses from Day 1 to Day 85 of the Treatment Period. Patients in Cohort 2 will receive weekly doses of 10 mg\u002Fkg for a total of 4 doses from Day 1 to Day 22 followed by biweekly doses at 20 mg\u002Fkg for a total of 5 doses from Day 29 to Day 85.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Rekha Bansal, PhD","CONTACT","2164402696","clinicalsae@novelmed.com",{"type":32,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100491824","phase-2-study-of-nm8074-in-patients-with-ahus-with-evidence-of-ongoing-thrombotic-microangiopathy-100491824",false,"NCT05684159","Study of NM8074 in Patients With aHUS With Evidence of Ongoing Thrombotic Microangiopathy","A Phase II, Open-Label Study of NM8074 in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)","Inclusion Criteria:\n\n* Patients ≥ 18 years at the time of consent\n* Patients with evidence of resistant or relapsed complement-mediated aHUS with symptoms of Thrombocytopenia, hemolysis, ongoing Thrombotic Microangiopathy and acute kidney injury.\n* Evidence of ongoing Thrombotic Microangiopathy which includes Haptoglobin \\\u003CLLN or undetectable and\u002For presence of schistocytes\n* Acute kidney injury (proteinuria\u002Fcreatinuria \\> ULN and\u002For reduced eGFR)\n* Platelets less than 150,000 per microliter (Thrombocytopenia)\n* Anemia (Hemoglobin ≤10 g\u002FdL) due to hemolysis\n* Lactate dehydrogenase (LDH) level ≥ 1.5 times the upper limit of normal (xULN) during Screening\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135 and MenB meningococcal serogroup B vaccine (Bexsero®). If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule.\n* Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to refrain from donating sperm for the duration of the study.\n* Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 month after stopping the investigational drug.\n\nExclusion Criteria:\n\n* History of bone marrow, hematopoietic stem cell, or solid organ transplantation\n* Treatment with complement blockers\n* Patients with infections\n* HUS due to ADAMTS-13 deficiency (\\\u003C5%)\n* Kidney disease other than aHUS\n* Chronic dialysis (hemo or peritoneal)\n* Liver disease or other major autoimmune diseases\n* Typical HUS (Shiga toxin +)\n* Known Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, or antiphospholipid antibody positivity or syndrome\n* History of currently active primary or secondary immunodeficiency\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections\n* Has a currently active or known history of meningococcal disease or N. meningitidis infection\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis)\n* Females who have a positive pregnancy test result at Screening or on Day 1.\n* Pregnant, planning to become pregnant, or nursing female subjects.","ALL","18 Years","65 Years",{"count":44,"type":45},12,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","This is a Phase II, open-label study designed to determine if intravenously administered NM8074 results in remission from TMA in treatment-naïve aHUS patients.",[51],"aHUS - Atypical Hemolytic Uremic Syndrome","NOT_YET_RECRUITING","2026-04-07",{"date":55,"type":56},"2026-04-13","ACTUAL",{"date":58,"type":45},"2027-11",{"date":60,"type":45},"2031-02",{"name":5,"class":6}]