Prospective, Single Arm and Open Clinical Observation of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

Who is this study for? Patients with antiphospholipid syndrome with secondary thrombocytopenia
What treatments are being studied? Zanubrutinib
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the safety and efficacy of zanubrutinib in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in 10 patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 and above, male or female;

• Diagnosis of antiphospholipid syndrome;

• Failure to receive glucocorticoid treatment in the past (the curative effect cannot be maintained, or recurs, or cannot be tolerated); Can not choose other second-line treatment, such as rituximab, cyclosporine, cyclophosphamide, etc.; Or rituximab, cyclosporine and other treatments are ineffective, relapsed or intolerable;

• Plt \< 30×10\^9/L;

• Liver and kidney function, such as ALT, AST, BUN, SCR \< 1.5 × upper limit of normal value, passing physical examination;

• ECOG physical state score ≤ 2 points;

• Cardiac function of the New York Society of Cardiac Function ≤ 2;

• Signed and dated written informed consent.

Locations
Other Locations
China
Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITING
Tianjin
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yunfei Chen, MD
chenyunfei@ihcams.ac.cn
+8618502220788
Time Frame
Start Date: 2022-01-25
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 10
Treatments
Experimental: Intervention ( zanubrutinib)
10 enrolled patients are picked up to take zanubrutinib at the indicated dose.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov