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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
320
TQB3473 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).
Time frame: Weeks 13-24
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);
Time frame: Within 12 weeks of 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 frame: Within 24 weeks of treatment
Time to Onset
The time from the initiation of treatment to the first platelet count ≥50×10\^9/L
Time frame: Within 24 weeks of treatment
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.
Time frame: Within 24 weeks of treatment
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The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, China
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
...and 41 more locations
The proportion of subjects who receive rescue treatment
The proportion of subjects who receive rescue treatment aimed to increase platelet counts within 24 weeks of treatment.
Time frame: Within 24 weeks of treatment
The incidence and severity of bleeding events
The incidence and severity of bleeding events evaluated according to the World Health Organization (WHO) bleeding scoring criteria within 24 weeks of treatment.
Time frame: Within 24 weeks of treatment
The change of concomitant therapy
The proportion of subjects who reduce or discontinue concomitant ITP treatments within 24 weeks of treatment.
Time frame: Within 24 weeks of treatment
Improvement in Quality of Life Score
Conduct a comprehensive evaluation of the physical condition of the subjects, and the higher the score, the better the subject's condition.
Time frame: Within 24 weeks of treatment
The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators.
The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators.
Time frame: Within 24 weeks of treatment
Area under the curve (0 to Infinity) after initial administration (AUC0-∞)
Main pharmacokinetic parameters, area under the curve (0 to Infinity) after initial administration (AUC0-∞)
Time frame: Within 24 weeks of treatment
Maximum plasma concentration (Cmax) after initial administration
Maximum plasma concentration (Cmax) after initial administration.
Time frame: Within 24 weeks of treatment
Elimination Half-Life(t1/2)after initial administration
Elimination Half-Life(t1/2)after initial administration.
Time frame: Within 24 weeks of treatment
Apparent clearance(CL/F)after initial administration
Apparent clearance(CL/F)after initial administration.
Time frame: Within 24 weeks of treatment
Apparent Volume of Distribution (Terminal Phase)(Vz/F)after initial administration
Apparent Volume of Distribution (Terminal Phase)(Vz/F)after initial administration.
Time frame: Within 24 weeks of treatment
Terminal elimination Rate Constant (λz) after initial administration
Terminal elimination Rate Constant (λz) after initial administration.
Time frame: Within 24 weeks of treatment
Area under the curve (0 to 24 hours) after multiple administration (AUC0-24h)
Area under the curve (0 to 24 hours) after multiple administration (AUC0-24h).
Time frame: Within 24 weeks of treatment
Area under the curve (0 to Infinity) after multiple administration (AUC0-∞)
Area under the curve (0 to Infinity) after multiple administration (AUC0-∞).
Time frame: Within 24 weeks of treatment
Minimum steady-state concentration (Css-min) after multiple administration
Minimum steady-state concentration (Css-min) after multiple administration.
Time frame: Within 24 weeks of treatment
Maximum steady-state concentration (Css-max) after multiple administration
Maximum steady-state concentration (Css-max) after multiple administration.
Time frame: Within 24 weeks of treatment
Average Steady-State Concentration (Css-avg) after multiple administration
Average Steady-State Concentration (Css-avg) after multiple administration.
Time frame: Within 24 weeks of treatment
Elimination Half-Life (t1/2) after multiple administration
Elimination Half-Life (t1/2) after multiple administration.
Time frame: Within 24 weeks of treatment
Apparent Clearance (CL/F) after multiple administration
Apparent Clearance (CL/F) after multiple administration.
Time frame: Within 24 weeks of treatment
Apparent volume of distribution (Steady State) after multiple administration (Vss/F)
Apparent volume of distribution (Steady State) after multiple administration (Vss/F).
Time frame: Within 24 weeks of treatment
Terminal Elimination Rate Constant (λz) after multiple administration
Terminal Elimination Rate Constant (λz) after multiple administration.
Time frame: Within 24 weeks of treatment
Accumulation ratio constant (Rac) after multiple administration
Accumulation ratio constant (Rac) after multiple administration.
Time frame: Within 24 weeks of treatment
Degree of fluctuation (DF) after multiple administration
Degree of fluctuation (DF) after multiple administration.
Time frame: Within 24 weeks of treatment