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

Ki vehet részt

• 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

Ki nem vehet részt

• Those who have received allogeneic stem cell transplantation or organ transplantation in the past
• 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
• Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up
• 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
• Patients whose toxic symptoms caused by pre-trial treatment have not disappeared
• Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients