Actively Recruiting
Phase 2 Study of Narsoplimab Treatment in Children 28 Days to Under 18 Years With High-Risk Hematopoietic Stem Cell Transplant Thrombotic Microangiopathy
Led by Omeros Corporation · Updated on 2025-03-25
18
Participants Needed
16
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating narsoplimab to study its safety and effectiveness in children with thrombotic microangiopathies TMA that happen after a hematopoietic stem cell transplant HSCT. This Phase 2 study focuses on pediatric patients aged from 28 days up to less than 18 years with high-risk HSCT-TMA. The study includes three age groups infants to under 2 years, children 2 to under 12 years, and adolescents 12 to under 18 years. Participants will receive a single dosing regimen of narsoplimab at 4 mgkg for 8 weeks. The treatment is given to all participants without a comparison group. After treatment, patients will be monitored and followed for up to 52 weeks to assess longer-term effects and outcomes. During the study, participants will have survival rates evaluated at 100 days and up to one year after diagnosis of high-risk HSCT-TMA. Researchers will monitor adverse events, clinical response, pharmacokinetics, and immune response to the drug. The study involves regular medical assessments and safety monitoring throughout the treatment and follow-up periods, lasting up to one year in total.
CONDITIONS
Brief Title
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
Research Team
O
Omeros Clinical Trial Information
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