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Monoclonal Antibodies

OMS721 for Atypical Hemolytic Uremic Syndrome (aHUS Trial)

Phase 3
Waitlist Available
Research Sponsored by Omeros Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-4; treatment maintenance (103 weeks): 17 visits; rescue therapy (if occurs): rt days 1-4; follow-up at day 771
Awards & highlights

aHUS Trial Summary

The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 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).

Eligible Conditions
  • Atypical Hemolytic Uremic Syndrome
  • Thrombotic Microangiopathy

aHUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-4; treatment maintenance (103 weeks): 17 visits; rescue therapy (if occurs): rt days 1-4; follow-up at day 771
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-4; treatment maintenance (103 weeks): 17 visits; rescue therapy (if occurs): rt days 1-4; follow-up at day 771 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The effect of OMS721 as measured by platelet count change from baseline
Secondary outcome measures
Change from baseline in haptoglobin
Change from baseline in serum LDH
Change from baseline in serum creatinine
+12 more

aHUS Trial Design

1Treatment groups
Experimental Treatment
Group I: OMS721Experimental Treatment1 Intervention
Administration of OMS721
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Narsoplimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Omeros CorporationLead Sponsor
28 Previous Clinical Trials
3,723 Total Patients Enrolled
Eckhard Leifke, M.D.Study DirectorOmeros Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome
2017. "Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03205995.
All > Autoimmune Hemolytic Anemia
~10 spots leftby May 2025
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