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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3473 Tablets | Active Comparator | TQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks. |
|
| TQB3473 Placebo | Placebo Comparator | Placebo, orally once daily for 24 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3473 Tablets | Drug | TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During the 24-week randomized double-blind treatment period (Weeks 14-24) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of secondary causes of ITP (e.g., untreated Helicobacter pylori infection, leukemia, lymphoma, history of autoimmune diseases such as systemic lupus erythematosus, Hashimoto's thyroiditis, etc.) or drug-induced causes (e.g., anticonvulsants, antibiotics, heparin, etc.), or immune-mediated cytopenia involving two or more cell lines such as Evans syndrome or immune-related cytopenia;
Subjects with a history or current diagnosis of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematologic diseases;
History of or concurrent other malignancies within the past 3 years. Exceptions include: other malignancies treated with a single surgical procedure and achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)];
Conditions affecting venous blood sampling or multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
Adverse reactions from previous treatments have not resolved to ≤CTCAE grade 1, except for non-clinically significant and asymptomatic laboratory abnormalities judged by the investigator to pose no safety risks;
Previous bone marrow/hematopoietic stem cell transplantation or major solid organ transplantation;
Vaccination within 8 weeks prior to randomization or planned vaccination during the study period;
Major surgical treatment or significant traumatic injury within 4 weeks prior to randomization, or anticipated need for major elective surgery during the study treatment period (major surgery is defined as level 3 or higher according to the National Surgical Classification Catalog 2022);
History of intracranial hemorrhage or other severe bleeding in vital organs (≥CTCAE grade 3), or symptomatic gastrointestinal bleeding (e.g., hematemesis, melena, etc., excluding asymptomatic "occult blood test positive" and hemorrhoids) within 6 months prior to screening;
Arterial/venous thrombotic events within 12 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism;
ITP-related symptoms and treatments:
Need for long-term/continuous use of medications affecting platelet function [including but not limited to aspirin, clopidogrel, ticagrelor, non-steroidal anti-inflammatory drugs (NSAIDs), etc.] or anticoagulant therapy;
Known allergy to the active ingredient or excipients of the investigational drug;
Previous treatment with Syk inhibitors;
Participation in another clinical trial and use of investigational drugs within 4 weeks prior to randomization;
Any condition judged by the investigator to pose a significant risk to the subject's safety or to affect the subject's ability to complete the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu Zhou, Doctor | Contact | 13939068863 | papertigerhu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of ustc anhui provincial hospital | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| TQB3473 Placebo | Drug | Placebo contains no active substance. |
|
| 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). | 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 | 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. | 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. | 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. | 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. | 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. | 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 |
| The First Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | 241001 | China |
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| Beijing Chaoyang Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
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| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| Nanfang Hospital, Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
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| Shenzhen Nanshan People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518000 | China |
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| Central People's Hospital of Zhanjiang | Not yet recruiting | Zhanjiang | Guangdong | 524045 | China |
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| The Second Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530005 | China |
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| The Affiliated Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | Guizhou | 550004 | China |
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| The First Affiliated Hospital of Hainan Medical University | Not yet recruiting | Haikou | Hainan | 570102 | China |
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| Affiliated Hospital of Hebei University / School of Clinical Medicine | Recruiting | Baoding | Hebei | 071000 | China |
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| Affiliated Hospital of ChengDe Medical University | Not yet recruiting | Chengde | Hebei | 067000 | China |
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| The First Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050023 | China |
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| North China University of science and technology | Not yet recruiting | Tangshan | Hebei | 063000 | China |
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| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
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| Anyang People's Hospital | Not yet recruiting | Anyang | Henan | 455112 | China |
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| Nanyang Central Hospital | Not yet recruiting | Nanyang | Henan | 473001 | China |
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| Xuchang Central Hospital | Not yet recruiting | Xuchang | Henan | 461000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The First People's Hospital of Ping Ding Shan | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| The Third Hospital of Changsha | Not yet recruiting | Changsha | Hunan | 410035 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| Affiliated Hospital of Nantong University | Not yet recruiting | Nantong | Jiangsu | 226006 | China |
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| Northern Jiangsu People's Hospital Affiliated to Yangzhou University | Not yet recruiting | Yangzhou | Jiangsu | 225009 | China |
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| Ganzhou People's Hospital | Not yet recruiting | Ganzhou | Jiangxi | 341001 | China |
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| The First Affiliated Hospital of NanChang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The first hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130400 | China |
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| Shenjing Hospital Of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| Qinghai University Affiliated Hospital | Not yet recruiting | Xining | Qinghai | 810000 | China |
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| Xijing Hospital | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| Xi'an No.3 Hospital | Not yet recruiting | Xi'an | Shaanxi | 710018 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Shandong First Medical University Affiliated Central Hospital | Not yet recruiting | Jinan | Shandong | 250013 | China |
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| Linyi Central Hospital | Not yet recruiting | Linyi | Shandong | 276401 | China |
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| Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University) | Not yet recruiting | Yantai | Shandong | 264099 | China |
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| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Affiliated Zhongshan Hospital of Fudan University,Qingpu Branch | Not yet recruiting | Shanghai | Shanghai Municipality | 201700 | China |
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| Heping Hospital affiliated to Changzhi Medical College | Not yet recruiting | Changzhi | Shanxi | 046000 | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300070 | China |
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| Tianjin People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300121 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Not yet recruiting | Ürümqi | Xinjiang | 830000830000 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| Kunming Medical University Second Affiliated Hospital | Not yet recruiting | Kunming | Yunnan | 650033 | China |
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| The First Affiliated Hospital of Zhejiang Chinese Medical University | Not yet recruiting | Hangzhou | Zhejiang | 310006 | China |
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| The First Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315020 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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