primary immune thrombocytopenia
Conditions
Interventions
Experimental group1:Zuberitamab 100mg/w x 4w
Experimental group2:Zuberitamab 300mg/w x 4w
Experimental group3:Zuberitamab 600mg/w x 4w
Control group:placebo/w x 4w
Sponsors
Union hospital tongji medical college huazhong university of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Understand the procedures and methods of this clinical trial, and sign the informed consent form voluntarily after sufficient informed consent; 2. Aged 18 to 70 year when signing the informed consent form, regardless of gender; 3. The time of clinical diagnosis of primary immune thrombocytopenia (ITP) is at least 6 months before randomization, and the corresponding medical records can be provided; and the primary ITP is confirmed by bone marrow examination during the screening period; 4. During the screening period, both platelet counts were = 60ml/min; total bilirubin <= 1.5 times the upper limit of the normal range, alanine aminotransferase (ALT) and aspartate Acid aminotransferase (AST) <= 3 times the upper limit of the normal range; 10. Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (APTT) must not exceed 20% of the normal reference range, and no coagulation other than ITP has ever occurred abnormal medical history; 11 WHO bleeding scale score <= 2 points; 12. Eastern Cooperative Oncology Group (ECOG) performance status score 0~2; 13. Females of childbearing age have a negative blood pregnancy test, and the subjects or their spouses must use hormonal contraceptives ( Effective contraception other than oral, injectable, or implantable dosage forms such as abstinence, IUDs, or double-barrier methods (eg, condoms and diaphragms), etc.
Exclusion criteria
Exclusion criteria: 1. Other secondary thrombocytopenia: due to autoimmune diseases other than ITP, thyroid diseases, lymphoproliferative diseases, myelodysplastic syndromes (MDS), aplastic anemia (AA), hematological malignancies , malignant tumor, chronic liver disease, hypersplenism, common variant immunodeficiency disease (CVID), infection, secondary thrombocytopenia caused by vaccination, etc.; platelet consumption decreased; drug-induced thrombocytopenia; alloimmune platelets reduction; gestational thrombocytopenia; congenital thrombocytopenia and pseudo-thrombocytopenia, etc.; 2. Those who have been allergic to any component of rituximab (or investigational drug) in the past; 3. Patients with arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction) or venous thrombosis (such as deep vein thrombosis, pulmonary embolism) who still need anticoagulation/antiplatelet therapy; 4. During the trial period, due to underlying diseases, it is necessary to continue taking non-steroidal anti-inflammatory drugs (aspirin, aspirin-containing compounds, salicylates, etc.), and anticoagulants (warfarin, clopidogrel, etc.) ) and other drugs that affect platelet function; 5. Prior treatment should be excluded if any of the following: (1) Within 2 weeks before the first administration, the subject has been treated with drugs that have an impact on platelet count or function for > 3 consecutive days (including but not limited to Chinese herbal medicine or nutritional additives, non-steroidal anti-inflammatory drugs, or anti-inflammatory drugs) coagulant therapy; except for maintenance background therapy drugs in the inclusion criteria); (2) Received immunosuppressive drugs and other drugs that can affect platelet count (such as interferon-a, etc., except for maintenance background therapy drugs in the inclusion criteria) within 4 weeks before the first administration; (3) Splenectomy. 6. Patients who have been diagnosed with antiphospholipid antibody syndrome or other autoimmune diseases (such as systemic lupus erythematosus); 7. Any active infection at the screening visit (including those with positive novel coronavirus nucleic acid test but no clinical symptoms); or infection requiring intravenous antibiotic treatment or hospitalization within 8 weeks; or oral infection within 2 weeks Infection treated with antibiotics; or symptoms due to infection within 1 week; 8. Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive, and the quantitative detection result of hepatitis C virus RNA is greater than the detection limit; hepatitis B surface anti (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and The quantitative detection result of hepatitis B virus DNA is greater than the lower limit of detection; 9. Those who have positive results of tuberculosis screening (chest X-ray and blood interferon-gamma release test) and are judged by the investigator to be active tuberculosis; 10. Patients who participated in other clinical trials within 30 days before the first dose or within 5 half-lives (whichever is longer) and received the experimental drug; or patients who participated in clinical trials of medical devices; 11. Have been vaccinated within 8 weeks before signing the informed consent form, or plan to be vaccinated during the trial or within half a year after the end of the trial; 12. Past history of malignant tumor; 13. Patients with severe concomitant dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet counts; | — |
Countries
China
Contacts
Public ContactHu Yu
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed