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Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome

NCT03205995 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-10

Study results available
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Summary

The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 (narsoplimab) in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA).

Conditions

  • Thrombotic Microangiopathies
  • Atypical Hemolytic Uremic Syndrome

Interventions

BIOLOGICAL

OMS721 (narsoplimab)

Intravenous loading dose followed by daily subcutaneous injections

Sponsors & Collaborators

  • Omeros Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2021-02-02
Completion
2021-02-02
FDA Drug
Yes

Countries

  • United States
  • Lithuania
  • Poland
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03205995 on ClinicalTrials.gov