TerminatedPhase 2

Telitacicept in Primary APS Patients

Stopped: There is no clear therapeutic effect among the enrolled patients for the time being.

China20 participantsStarted 2021-07-01

Plain-language summary

This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * meet 2006 Sapporo classification criteria of APS; * diagnosis of primary APS, exclude other etiologies of thrombosis; * with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody; * with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations. Exclusion Criteria: * overlap with other connective tissue diseases, such as systemic lupus erythematosus; * during pregnancy; * can not follow-up.

What they're measuring

new thrombotic event

Timeframe: 24 weeks

Trial details

NCT IDNCT05078710

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

View on ClinicalTrials.gov More Anti Phospholipid Syndrome trials