Telitacicept in Primary APS Patients
Key facts
- Who runs it
- Peking Union Medical College Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 20 people enrolled
- Started
- 1 Jul 2021
- Ended
- 1 Jun 2025
- Type of study
- Interventional
- Treatments tested
- Telitacicept
- Record updated
- 8 June 2025
- Why it stopped
- There is no clear therapeutic effect among the enrolled patients for the time being.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- overlap with other connective tissue diseases, such as systemic lupus erythematosus
- during pregnancy
- can not follow-up
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Telitacicept armTreatment being tested
Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.
Treatment: Telitacicept
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Study of Telitacicept Treatment in Primary APS Patients
- Record updated
- 8 June 2025