Last updated on February 2018

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies


Brief description of study

The purpose of this study is to assess the safety, tolerability, and clinical activity of OMS721 in subjects with thrombotic microangiopathies (TMA), which include atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell transplant -associated TMA (HSCT-associated TMA). The study will also evaluate clinical activity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA).

Detailed Study Description

This is a Phase 2, uncontrolled, three-stage, dose-escalation cohort study in subjects with three forms of TMA: atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell transplant -associated TMA (HSCT-associated TMA). In the first stage, OMS721 will be administered to escalating dose cohorts of three subjects per cohort to identify the optimal dosing regimen. In the second stage, the dose selected in the first stage will be administered to expanded cohorts of 40 subjects per cohort with distinct etiologies (aHUS alone in one cohort and TTP or HSCT-TMA in the other cohort). Subjects completing the second stage may be eligible for continued treatment in the third stage if the investigator believes the subject is at risk for relapse of TMA, the subject tolerated OMS721 treatment, and the subject has no conditions that increase the risk of OMS721 treatment.

Clinical Study Identifier: NCT02222545

Contact Investigators or Research Sites near you

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Soyoung Han

Omeros Investigational Site
Christchurch, New Zealand
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Recruitment Status: Open


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