Chronic ITP (12 months)
Conditions
Interventions
experimental group:TQB3473
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject volunteered to join the study and signed the informed consent form (ICF) with good compliance; 2. Male or female between the ages of 18 and 75 (calculated based on the date of signing the informed consent form); 3. ECOG score of 0-1; 4. Primary ITP was diagnosed before randomization and lasted for 12 months; 5. Mean of at least 3 independent platelet counts (more than 3 days apart) within 3 months before randomization 35×10^9 / L; and no severe bleeding within 4 weeks prior to screening; 6. Previous glucocorticoid therapy with treatment refractory to at least one standard ITP treatment or relapse after treatment. Inefficacy was defined as post-treatment platelet count 1.5×10^9 / L; hemoglobin (Hb) >=100g / L; Total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=1.5 upper limit of normal (ULN); Serum creatinine of <=1.5 ULN, and creatinine clearance of 50 mL/min; Serum amylase, lipase <=1.5 ULN; The prothrombin time (PT) did not exceed the normal range +/- 3s, and the activated partial thromboplastin time (APTT) did not exceed the normal range =/- 10s; 11. No history of coagulopathy other than ITP; 12. Women of childbearing age should agree to effective contraception during the study and within 6 months after completion of study treatment, and a negative serum or urine pregnancy test within 7 days before study enrollment; men should agree to effective contraception during the study and within 6 months after completion of study treatment,;
Exclusion criteria
Exclusion criteria: 1. There is evidence that the subject has secondary causes of ITP (e. g., untreated H. pylori infection, leukemia, lymphoma, autoimmune disease history such as systemic lupus erythematosus, Hashimoto's thyroiditis, etc.) or drugs (e. g., anticonvulsants, antibiotics, heparin, etc.), or two lines and more immune cytopenia such as Evans syndrome, immune-related hemocytopenia, etc.; 2. The subject had previous or current myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disease, or other hematological malignancies; 3. Present of, or currently, other malignancies in the previous 3 years. The following two conditions can be enrolled: disease-free survival (DFS) for other malignancies treated with single surgery; cured cervical carcinoma in situ, skin cancer without melanoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 4. There are diseases affecting venous blood collection, or multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 5. Adadverse effects of previous treatment failed to recover to grade CTCAE 1, except for non-clinically significant and asymptomatic laboratory abnormalities such as toxicity judged without safety risk; 6. Patients who have received previous bone marrow / hematopoietic stem cell transplantation or important solid organ transplantation; 7. Vaccination within 8 weeks before randomization or planned during the study; 8. Those who have received major surgical treatment, significant traumatic injury or need major elective surgery during expected study treatment within 4 weeks before randomization (major surgery is defined as grade 3 or above in the National Surgical Classification Catalogue 2022); 9. Patients with a history of intracranial hemorrhage or severe hemorrhage of other important organs (Grade >=CTC AE 3), or a history of symptomatic gastrointestinal hemorrhage (such as hematemesis, melena, etc., asymptomatic "positive occult blood test" and hemorrhoids) within 6 months prior to screening; 10. Active / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, occurred within 12 months before randomization; 11. Human immunodeficiency virus (HIV) infection, or active viral hepatitis with poor control, or liver cirrhosis, or hepatic encephalopathy history. Viral hepatitis can be screened for: HBsAg positive subjects must meet HBV DNA quantification =140mmHg or diastolic >=90mmHg after treatment with 2 drugs); Cardiac insufficiency according to New York Cardiology Association (NYHA, Grade III-IV); History of clinically significant ventricular arrhythmia (e. g. persistent ventricular tachycardia, ventricular fibrillation, torsade pointes) or arrhythmia requiring continuous antiarrhythmic drug therapy; Unstable angina pectoris or previous myocardial infarction in the 12 months prior to randomization; The Fridericia-corrected QT interval (QTcF) was> 450 ms (msec) in men and> 470 msec in women (if QTc is abnormal, three consecutive tests for more than 2 mi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous Efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of bleeding events;Proportion of emergency treatment;Changes in combined treatment; | — |
Countries
China
Contacts
Public ContactHu Zhou
HenanCancerHospital
Outcome results
None listed