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Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:
A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Pediatric Patients (28 Days to ≤ 18 Years of Age.) With High-Risk Hematopoietic Stem Cell Transplant Thrombotic Microangiopathy

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT).

Clinical Trial Description

This is a Phase 2, uncontrolled, single-dosing regimen study in pediatric patients from 28 days to less than 18 years of age with high risk HSCT-TMA. At least 4 patients will be required from each of 3 age cohorts: 28 days to <2 years of age, 2 years to <12 years of age, and 12 years to <18 years of age. Treatment will be for 8 weeks and patients will be followed for up to 52 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05855083
Study type Interventional
Source Omeros Corporation
Contact Omeros Clinical Trial Information
Phone 206-676-5000
Email ctinfo@omeros.com
Status Recruiting
Phase Phase 2
Start date May 1, 2023
Completion date December 2025
View Details
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