Status:
COMPLETED
Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
Lead Sponsor:
Omeros Corporation
Conditions:
Thrombotic Microangiopathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).
Detailed Description
This is a Phase 2, uncontrolled, 3-stage, ascending-dose-escalation study in patients with 1 of 3 forms of TMA: atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hemato...
Eligibility Criteria
Inclusion
- Are at least age 18 at screening (Visit 1)
- Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP
- No clinically apparent alternative explanation for thrombocytopenia and anemia
Exclusion
- Had eculizumab therapy within three months prior to screening
- Have STEC-HUS
- Have a positive direct Coombs test
- Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed)
Key Trial Info
Start Date :
November 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02222545
Start Date
November 2 2014
End Date
August 11 2020
Last Update
August 28 2024
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Omeros Investigational Site
Duarte, California, United States, 91010
2
Omeros Investigational Site
Rochester, Minnesota, United States, 55905
3
Omeros Investigational Site
New York, New York, United States, 10065
4
Omeros Investigational Site
Durham, North Carolina, United States, 27710