A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune 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 immune thrombocytopenia in 30 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；

• Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)；

• Diagnosis of ITP>3 months；

• Primary ITP with a platelet count of <30 X 109/L prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab >12 weeks ago and/or TPO-RAs.

• 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 pulmonary embolism, thrombosis and atherosclerosis;

• 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;

• Patients taking antiplatelet drugs at the same time;

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