Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia
Recruiting now · Phase 2
Conditions studied: Antiphospholipid Syndrome, Thrombocytopenia, Treatment
In brief
To evaluate the safety and efficacy of zanubrutinib in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in 10 patients.
Key facts
- Study ID
- NCT05199909
- Run by
- Institute of Hematology & Blood Diseases Hospital, China
- People needed
- 10
- Starts
- 2022-01-25
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2025-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, Tianjin Municipality, China (enrolling)
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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