This study is an extension of the TQB3473-III-01 study, aimed at evaluating the safety and efficacy of TQB3473 tablets in adult patients with persistent or chronic ITP who have received at least one ITP standard treatment that is ineffective or has recurred after treatment. This is a single arm, open label, multi cohort, multi center Phase II clinical study.
Voluntarily participate in this study with signed informed consent form (ICF) and demonstrated good compliance.
Age ≥18 years (calculated from the date of ICF signing); no gender restrictions; Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Clinically stable condition with WHO bleeding scale score 0-1, and investigator assessment indicates no need for emergency treatment within the next 2 weeks.
No increase in the type, dosage, or frequency of concomitant ITP medications compared to the TQB3473-III-01 study regimen.
Due to reasons other than lack of efficacy, receiving TQB3473-III-01 study treatment for less than 12 weeks.
Hepatitis B Virus (HBV) DNA or Hepatitis C Virus (HCV) RNA detection values exceeding the upper limit of normal or decompensated cirrhosis
Previous intracranial hemorrhage or severe bleeding of other important organs (≥ CTC AE grade 3), or symptomatic gastrointestinal bleeding (such as vomiting blood, black stool, etc., except for asymptomatic and asymptomatic "occult blood test positive" and hemorrhoids) within the 6 months before enrollment.
Suffering from major cardiovascular and cerebrovascular diseases.
Single group
TQB3473 Tablets
DrugTQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
Sustained response rate
During the last 12 weeks of treatment, at least 2 platelet counts were ≥50×10\^9/L in three protocol-determined visits (excluding rescue treatment).
Response rate at 12 weeks
① The percentage of patients with platelet count ≥ 50×10\^9/L at least once within 12 weeks of treatment (excluding emergency treatment). ② The percentage of subjects with a baseline platelet count of\<15 × 10\^9/L who have had at least one platelet count of ≥ 30×10\^9/L within 12 weeks of treatment and an increase of ≥ 20 × 10\^9/L from baseline (excluding emergency treatment);
Response rate at 24 weeks
* The percentage of patients with platelet count ≥ 50×10\^9/L at least once within 24 weeks of treatment (excluding emergency treatment). * The percentage of subjects with a baseline platelet count of\<15 × 10\^9/L who have had at least one platelet count of ≥ 30×10\^9/L within 24 weeks of treatment and an increase of ≥ 20 × 10\^9/L from baseline (excluding emergency treatment); ③ The percentage of subjects with platelet counts at least twice the baseline level and ≥30×10\^9/L for at least two consecutive measurements within 24 weeks of treatment (excluding rescue treatment).
Time to Onset
The time from the initiation of treatment to the first platelet count ≥50×10\^9/L
The cumulative duration of platelet count ≥ 50 × 10^9/L within 24 weeks of treatment
The cumulative duration of platelet count ≥ 50 × 10\^9/L within 24 weeks of treatment.
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