This is a randomized, double-blind, placebo-controlled Phase III clinical study designed to demonstrate that TQB3473 tablets significantly improve the sustained response rate compared to placebo in adult patients with chronic ITP who have previously received standard corticosteroid therapy and have failed or relapsed after at least one standard ITP treatment. The study consists of a treatment period and a safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
199
TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
Placebo contains no active substance.
The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
NOT_YET_RECRUITINGBeijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
Durable response rate: platelet counts ≥50×10^9/L
During the 24-week randomized double-blind treatment period (Weeks 14-24), platelet counts ≥50×10\^9/L in at least 4 out of the 6 protocol-specified visits (excluding rescue treatment).
Time frame: During the 24-week randomized double-blind treatment period (Weeks 14-24)
The effectiveness rate within the first 12 weeks of treatment
①The proportion of subjects with at least one platelet count ≥50×10\^9/L during weeks 1-12 (excluding emergency treatment).②Among subjects with a baseline platelet count \<15×10\^9/L, the proportion of subjects with at least one platelet count ≥30×10\^9/L and an increase of ≥20×10\^9/L from baseline during weeks 1-12 (excluding rescue treatment).
Time frame: Baseline to 12 weeks
The response rate within 24 weeks of treatment
① The proportion of subjects with at least one platelet count ≥50×10\^9/L during weeks 1-24 (excluding rescue treatment). ② Among subjects with a baseline platelet count \<15×10\^9/L, the proportion of subjects with at least one platelet count ≥30×10\^9/L and an increase of ≥20×10\^9/L from baseline during weeks 1-24 (excluding rescue treatment). ③ The proportion of subjects with platelet counts at least twice the baseline level and ≥30×10\^9/L for at least two consecutive measurements during weeks 1-24 (excluding rescue treatment).
Time frame: 24 weeks
Time to response: The time from the initiation of treatment to the first platelet count ≥50×10^9/L
The time from the initiation of treatment to the first platelet count ≥50×10\^9/L
Time frame: The time from the initiation of treatment to the first platelet count ≥50×10^9/L (excluding rescue treatment)
The incidence and severity of bleeding events (Weeks 1-12)
During Weeks 1-12 of the double-blind treatment period, the incidence and severity of bleeding events as assessed by the World Health Organization (WHO) bleeding score.
Time frame: During Weeks 1-12 of the double-blind treatment period
The incidence and severity of bleeding events (Weeks 1-24)
During Weeks 1-24 of the double-blind treatment period, the incidence and severity of bleeding events as assessed by the World Health Organization (WHO) bleeding score.
Time frame: During Weeks 1-24 of the double-blind treatment period
The proportion of subjects who receive rescue treatment
The proportion of subjects who receive rescue treatment aimed to increase platelet counts during the 24-week double-blind treatment period.
Time frame: During the 24-week double-blind treatment period
The change of concomitant therapy
The proportion of subjects who reduce or discontinue concomitant ITP treatments during the 24-week double-blind treatment period.
Time frame: During the 24-week double-blind treatment period
The incidence and severity of adverse events
The proportion of subjects experiencing adverse events and the severity of these events, with adverse events assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From the signing of the informed consent until 28 days after the last dose of study drug or the initiation of new ITP treatment, whichever occurs first
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGShenzhen Nanshan People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGCentral People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITING...and 43 more locations