Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
Phase 2
Completed
- Conditions
- Thrombotic Microangiopathies
- Registration Number
- NCT02222545
- Lead Sponsor
- Omeros Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> 1. Are at least age 18 at screening (Visit 1)<br><br> 2. Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP<br><br> 3. No clinically apparent alternative explanation for thrombocytopenia and anemia<br><br>Exclusion Criteria:<br><br> 1. Had eculizumab therapy within three months prior to screening<br><br> 2. Have STEC-HUS<br><br> 3. Have a positive direct Coombs test<br><br> 4. Have an active systemic bacterial or fungal infection requiring antimicrobial<br> therapy (prophylactic antimicrobial therapy administered as standard of care is<br> allowed)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA;Number of Participants With HSCT-TMA Who Respond to OMS721
- Secondary Outcome Measures
Name Time Method