Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhang Lei
• Treatments: Zanubrutinib

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases；

• HIV positive;

• Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;

• Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;

• At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;

• Patients with thrombotic diseases such as new pulmonary embolism and unstable period of various arteriovenous thrombosis;

• Those who have received allogeneic stem cell transplantation or organ transplantation in the past;

• Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;

• Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;

• Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer，etc.);

• Patients with septicemia or other irregular severe bleeding;

• Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.