RecruitingPhase 2NCT05855083

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

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


Sponsor

Omeros Corporation

Enrollment

18 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 28 DaysMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Biological: narsoplimab for people with hematopoietic stem cell transplantation and thrombotic microangiopathies. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 28 Days to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBiological: narsoplimab

Treatment with narsoplimab 4 mg/kg will be administered


Locations(16)

Omeros Investigational Site

San Diego, California, United States

Omeros Investigational Site

Gainesville, Florida, United States

Omeros Investigational Site

Boston, Massachusetts, United States

Omeros Investigational Site

St Louis, Missouri, United States

Omeros Investigational Site

New York, New York, United States

Omeros Investigational Site

Valhalla, New York, United States

Omeros Investigational Site

Houston, Texas, United States

Omeros Investigational Site

Seattle, Washington, United States

Omeros Investigational Site

Halle, Germany

Omeros Investigational Site

Hanover, Germany

Omeros Investigational Site

Haifa, Israel

Omeros Investigational Site

Jerusalem, Israel

Omeros Investigational Site

Ramat Gan, Israel

Omeros Investigational Site

Tel Aviv, Israel

Omeros Investigational Site

Utrecht, Netherlands

Omeros Investigational Site

Pamplona, Spain

View Full Details on ClinicalTrials.gov

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NCT05855083


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