CompletedPhase 2

Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

United States58 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 range18 Years

SexALL

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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)

What they're measuring

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.

Number of Participants With HSCT-TMA Who Respond to OMS721

Timeframe: Day 1 to up to 2 years following the first dose of OMS721

Trial details

NCT IDNCT02222545

SponsorOmeros Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-30

Results submitted2023-08-04

View on ClinicalTrials.gov More Thrombotic Microangiopathies trials