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

(aHUS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Omeros Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Inclusion Criteria

Competent to provide informed consent, or if a minor, have at least one parent or legal guardian to provide informed consent with written assent from the subject.

Are at least 12 years old at screening (Visit 1).

Have a clinically diagnosis of primary atypical hemolytic uremic syndrome (aHUS), with ADAMTS13 activity greater than 5% in plasma.

Treatment Details

Interventions

• OMS721 (Monoclonal Antibodies)

Participant Groups

Group I: OMS721 Experimental Treatment 1 Intervention

Administration of OMS721

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Omeros Investigational Site Los Angeles, CA

Omeros Investigational Site Chicago, IL

Who Is Running the Clinical Trial?

Omeros Corporation Lead Sponsor

References