Last updated: November 30, 2022
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Antiphospholipid Syndrome
Platelet Disorders
Thrombosis
Treatment
N/AClinical Study ID
NCT05644210
Bioagents in APS QiluH
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1.Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandardAPS performance; 2.Patients who meet 1997 or 2019 SLE classification criteria ; 3.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart; 4.with at least one extra-criteria manifestations of APS, including thrombocytopenia,hemolytic anemia, nephropathy, valve heart disease ,skin ulcer and arterial or deepvein thrombosis; 5.Maintain a stable base treatment regimen for at least 4 weeks before screening;Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, andhydroxychloroquine; 6.No response, intolerance or dependence on glucocorticoids and immunosuppressants; 7.Patients who had previously used beliumab or Telitacicept could be enrolled in thestudy after 12 weeks of discontinuation; 8.Age ≥18 years; 9.Signed Informed consent.
Exclusion
Exclusion Criteria:
- 1.Patients with other causes of thrombocytopenia, hemolytic anemia, valvular heartdisease, kidney disease and skin ulcer symptoms were excluded, such as drugs,infections, blood system diseases, genetic metabolic diseases, etc; 2.Severe cardiovascular diseases, kidney, liver and other important organ injuries,serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis,etc.) were excluded; A history of active malignancy (within 5 years) was excluded andchemoradiotherapy was performed; Patients with organ or bone marrow transplantation inthe past year were excluded. Exclusion of mentally ill persons; 3.A history of allergy to the relevant test drug; 4.Patients had recently received a live vaccine or planned to use any live vaccineduring the study; 5.Ongoing pregnancy; 6.Patients who were participants in clinical trials of other immunosuppressiveagents/biologics within 24 weeks; 7.Other conditions that the investigator considers would make the candidate unsuitablefor the study;
Study Design
Total Participants: 80
Study Start date:
October 01, 2022
Estimated Completion Date:
December 30, 2025
Study Description
Connect with a study center
Qilu Hospital
Jinan, Shandong Shandong
ChinaActive - Recruiting

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