drugset / Trial / NCT05078710

Telitacicept in Primary APS Patients

NCT05078710

Phase 2 Terminated 20 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-07-01
Primary completion
2022-07-01
Completion
2025-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Telitacicept Protein / enzyme biologic 160 mg