Immune Thrombocytopenia (ITP)
Conditions
Interventions
Experimental group:TQB3473 tablets
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent voluntarily, and the expected survival time is more than 3 months; 2. No gender limit, aged 18-75 years; physical performance score (Eastern Collaborative Oncology Group (ECOG) score) 0-2; 3. ITP has been diagnosed before screening (platelet loss has been sustained for more than 6 months); 4. At least ITP fails to respond to first-line treatment, or relapses after treatment; or poor effect on splenectomy or postoperative recurrence; 5. The mean value of at least 2 independent platelet counts (with an interval of more than 24 hours) within 2 months before screening was 35x10^9/L; 6. Laboratory tests meet the following conditions: (1) Hemoglobin >90 g/L, neutrophil >1.5x10^9/L; (2) Total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =50mL/min; (3) Serum amylase or lipase did not exceed the upper limit of the normal range; (4) The international normalized ratio (INR) does not exceed the normal value range of ± 3S; the value of activated partial thromboplastin time (APTT) did not exceed the normal range of ±10s.
Exclusion criteria
Exclusion criteria: 1. Combined diseases and medical history: (1) Secondary thrombocytopenia; or autoimmune diseases other than ITP that require long-term treatment with hormones or immunosuppressants; (2) Myelofibrosis, myelodysplastic syndrome, aplastic anemia, or other hematological malignancies; (3) Patients with previous history of malignant tumor; (4) Multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction); (5) Major surgery was performed within 4 weeks before randomization; or requiring major elective surgery during the study period; (6) Previous/associated major arterial/venous embolic disease; (7) Patients with a history of drug abuse or mental disorders; (8) Known to be allergic to the active ingredient or excipient of the study drug; (9) A history of immunodeficiency, including being HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (10) Known to have active pulmonary tuberculosis. 2. ITP related symptoms and treatment: (1) Received emergency treatment for ITP within 2 weeks before randomization; (2) Previous treatment with a splenic tyrosine kinase (SYK) inhibitor such as Fostamatinib; (3) Pregnant and lactating patients; (4) Participated in other clinical trials within 4 weeks before randomization; (5) According to the judgment of the researcher, there are concomitant diseases that seriously endanger patient safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet count;Dose limited toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding Score of ITP International Collaboration Group; | — |
Countries
China
Contacts
Public ContactZhou Hu
He'nan Cancer Hospital
Outcome results
None listed