Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies (NCT02222545) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
United States, Belgium, Bulgaria58 participantsStarted 2014-11-02
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA
Timeframe: Day 1 to 37 days after end of treatment, approximately up to 31 weeks.
2
Number of Participants With HSCT-TMA Who Respond to OMS721
Timeframe: Day 1 to up to 2 years following the first dose of OMS721