Telitacicept in Primary APS Patients

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05078710
Phase
PHASE2
Status
Terminated

Conditions

  • Anti Phospholipid Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 1, 2021
Status verified
Jul 2021
Primary completion
Jul 1, 2022
Completion
Jun 1, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept arm
    Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.

Primary Outcome Measure

new thrombotic event [ Time Frame: 24 weeks ]