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

Part of paid clinical trials in San Diego, California.

Sponsor
Omeros Corporation
Study ID
NCT05855083
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hematopoietic Stem Cell Transplantation
  • Thrombotic Microangiopathies

Eligibility Criteria

Sex
ALL
Age
28 Days - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Biological: narsoplimab — DRUG
    Treatment with narsoplimab 4 mg/kg will be administered

Study Details

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).

Key Dates

Start date
May 1, 2023
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Narsoplimab single arm-treatment
    Narsoplimab 4 mg/kg

Primary Outcome Measure

100-day survival rate following high-risk HSCT-TMA diagnosis. [ Time Frame: 100 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Omeros Investigational SiteSan DiegoCalifornia92024-
Omeros Investigational SiteGainesvilleFlorida32608-
Omeros Investigational SiteBostonMassachusetts02215-
Omeros Investigational SiteSt LouisMissouri63104-
Omeros Investigational SiteNew YorkNew York10065-
Omeros Investigational SiteValhallaNew York10595-
Omeros Investigational SiteHoustonTexas77030-
Omeros Investigational SiteSeattleWashington98105-

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