Primary Immune ThrombocytopeniaPhase 3NCT06900920
A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
A Phase 3 study testing TQB3473 Tablets in people with Primary Immune Thrombocytopenia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 53 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- TQB3473 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 53 sitesChina
- Study dates
- 30 Apr 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily join this study, sign the informed consent form (ICF), and demonstrate good compliance;
- Male or female subjects aged 18 to 75 years (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Diagnosis of primary ITP prior to randomization, with a duration of ≥12 months;
- An average of at least three independent platelet counts (spaced more than 3 days apart) within the 3 months prior to randomization <30×10^9/L, with no count >35×10^9/L; and no severe bleeding within 4 weeks prior to screening;
- Previous treatment with glucocorticoids and at least one standard ITP therapy that was ineffective or resulted in relapse.
- Female subjects of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment, with a negative serum or urine pregnancy test within 7 days prior to study enrollment; male subjects must agree to use effective contraception during the study and for 6 months after the end of study treatment, as detailed in Section 5.5.
Who cannot join
- 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;
Show all 20Show fewer
- 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:
- Receipt of immunoglobulins or platelet transfusions within 2 weeks prior to randomization;
- Receipt of treatments aimed at increasing platelet counts (including but not limited to glucocorticoids, Thyroid peroxidase (TPO), Thrombopoietin receptor agonists (TPO-RAs), cyclosporine, herbal medicines, etc.) within 4 weeks prior to randomization, except for those meeting inclusion criterion (8);
- Use of rituximab or other anti-cluster of differentiation 20 (CD20) drugs within 14 weeks prior to randomization;
- Splenectomy within 12 weeks prior to randomization.
- 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.
Trial locations and contacts
53 sites in 1 country. Contact the study team or a site near you to ask about taking part.
53 sites in 1 country
China53 sites, 53 recruiting
- Not yet recruiting
Anyang People's Hospital
Anyang, Henan, 455112
Zhengrong Liu, Doctor, 13837203600, 13837203600@139.com
- Recruiting
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, 071000
Hua Xue, Doctor, 15031273319, xh-xuehua@163.com
- Not yet recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Aijun Liu, Doctor, 13521030376, laj0628@163.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Huacong Cai, Doctor, 13651171155, CaiHC@pumch.cn
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130400
Sujun Gao, Doctor, 15843073208, sujung1963@sina.com
- Not yet recruiting
The Third Hospital of Changsha
Changsha, Hunan, 410035
Zengmei Sheng, Master, 13308458926, shengzengmei@163.com
- Not yet recruiting
Heping Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000
Xuliang Shen, Doctor, 13015365546, shenxlcyp@sohu.com
- Not yet recruiting
Affiliated Hospital of ChengDe Medical University
Chengde, Hebei, 067000
Zhihua Zhang, Master, 15633142905, zzhangzhihua@163.com
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Hanqing Zeng, Doctor, 18523394870, 233318983@qq.com
- Not yet recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001
Xiangzhou Du, Bachelor, 13576686139, jxdxz1989@163.com
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jieyu Ye, Doctor, 18988932111, jieyu.ye@gmail.com
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Jishi Wang, Doctor, 13639089646, Wangjishi9646@163.com
- Not yet recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Lu Xu, Doctor, 13518073033, xulu2324@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
Qinghong Yu, Doctor, 13575758729, ealeyu@126.com
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Shengjin Fan, Doctor, 13304641978, fansj1129@sohu.com
- Not yet recruiting
The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, 230001
Changcheng Zheng, Doctor, 18956073079, zhengchch1123@163.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Ming Hou, Doctor, 18560087028, houming@medmail.com
- Not yet recruiting
Shandong First Medical University Affiliated Central Hospital
Jinan, Shandong, 250013
Yun Chen, Doctor, 13370582720, chyun008@163.com
- Not yet recruiting
Kunming Medical University Second Affiliated Hospital
Kunming, Yunnan, 650033
Zepin Zhou, Doctor, 18788571605, 1580837415@qq.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Yaming Xi, Doctor, 13919110815, xiyaming02@163.com
- Not yet recruiting
Linyi Central Hospital
Linyi, Shandong, 276401
Guitao Jie, Master, 13869997389, guitaojie@126.com
- Not yet recruiting
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006
Fei Li, Doctor, 13970038386, yx021021@sina.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Rongfu Zhou, Doctor, 13605142342, rfzhoucn@163.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangsheng He, Doctor, 15312052798, heguangsheng1972@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530005
Yinghui Lai, Doctor, 13977187876, yinghuilai@sina.com
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006
Lu Zhou, Doctor, 18761720268, xueyezhoulu2007@sina.com
- Not yet recruiting
Nanyang Central Hospital
Nanyang, Henan, 473001
Chao Li, Bachelor, 18336637929, 18336637929@163.com
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Yongcheng Sun, Master, 15767800004, sunyc1983@126.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030
Chunkang Chang, Doctor, 13764643870, changchunkang7010@aliyun.com
- Not yet recruiting
Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch
Shanghai, Shanghai Municipality, 201700
Fanli Hua, Doctor, 18116017032, huafanli@163.com
- Not yet recruiting
Shenjing Hospital Of China Medical University
Shenyang, Liaoning, 110000
Aijun Liao, Doctor, 18940259833, liaoaijun@sina.com
- Not yet recruiting
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, 518000
Zhi Guo, Doctor, 13671053558, guozhi77@126.com
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023
Huiming Zhang, Doctor, 18633889276, zhanghuimina@sina.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Shaolong He, Master, 19935261898, hsl393@163.com
- Not yet recruiting
North China University of science and technology
Tangshan, Hebei, 063000
Zhenyu Yan, Doctor, 18831508262, hbyzy2011@163.com
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070
Rong Fu, Doctor, 13920350233, furong8369@tmu.edu.cn
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
Xingli Zhao, Doctor, 13752255454, tjsrmyyxyk@163.com
- Not yet recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000830000
Yan Li, Master, 13639935315, 1iyan232917@sina.com
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Xinhong Guo, Master, 15292898288, guoxinhong222@sina.cn
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Heng Mei, Doctor, 13886160811, mayheng@126.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Fuling Zhou, Doctor, 18986265580, zhoufuling@163.com
- Not yet recruiting
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
Hesheng He, Master, 15255378879, hhsmed2012@126.com
- Not yet recruiting
Xijing Hospital
Xi'an, Shaanxi, 710000
Guangxun Gao, Doctor, 13991907320, Gaoguangxun@fmmu.edu.cn
- Not yet recruiting
Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018
Xiequn Chen, Doctor, 13991832567, Cxq@nwu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Pengcheng He, Doctor, 18991232609, Hepc_gcp@163.com
- Not yet recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Hui Geng, Master, 13519775270, gh0227@sina.com
- Not yet recruiting
Xuchang Central Hospital
Xuchang, Henan, 461000
Shuhao Mei, Master, 13598980411, 13598980411@139.com
- Not yet recruiting
Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Yangzhou, Jiangsu, 225009
Mei Sun, Master, 18051060605, smzgwj@126.com
- Not yet recruiting
Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
Yantai, Shandong, 264099
Junjie Ma, Master, 18660487687, mjjshj@sina.com
- Not yet recruiting
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, 524045
Guocai Wu, Master, 13553564019, deanwgc@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Liu Liu, Doctor, 15936230382, liuliuxx1983@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Hu Zhou, Doctor, 13939068863, papertigerhu@163.com
- Not yet recruiting
The First People's Hospital of Ping Ding Shan
Zhengzhou, Henan, 450003
Zhanfang Wang, Master, 13393798910, pdssyyllb@126.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia (ITP)
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.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- TQB3473 Tablets, TQB3473 Placebo
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3473 TabletsDrug
TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
TQB3473 PlaceboDrug
Placebo contains no active substance.
| Study group | Role | What they receive |
|---|---|---|
| TQB3473 Tablets | Active comparator | TQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks. Receives: Drug: TQB3473 Tablets |
| TQB3473 Placebo | Placebo comparator | Placebo, orally once daily for 24 consecutive weeks. Receives: Drug: TQB3473 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the 24-week randomized double-blind treatment period (Weeks 14-24)
Secondary outcomes (8)
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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start30 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900920
- Sponsor's protocol ID
- TQB3473-III-01
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT06900920
- Acronym / sponsor ID
- TQB3473-III-01
- Conditions
- Primary Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB3473 Tablets | Active comparator | Drug: TQB3473 TabletsTQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks. |
| TQB3473 Placebo | Placebo comparator | Drug: TQB3473 PlaceboPlacebo, orally once daily for 24 consecutive weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects voluntarily join this study, sign the informed consent form (ICF), and demonstrate good compliance;
- Male or female subjects aged 18 to 75 years (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Diagnosis of primary ITP prior to randomization, with a duration of ≥12 months;
- An average of at least three independent platelet counts (spaced more than 3 days apart) within the 3 months prior to randomization <30×10^9/L, with no count >35×10^9/L; and no severe bleeding within 4 weeks prior to screening;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3473 TabletsTQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor. | Drug | TQB3473 Tablets |
| TQB3473 PlaceboPlacebo contains no active substance. | Drug | TQB3473 Placebo |
Primary outcome
Durable response rate: platelet counts ≥50×10^9/L
Time frame: During the 24-week randomized double-blind treatment period (Weeks 14-24)
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).
8 secondary outcomes
The effectiveness rate within the first 12 weeks of treatment
Time frame: Baseline to 12 weeks
The response rate within 24 weeks of treatment
Time frame: 24 weeks
Time to response: 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)
Time frame: During Weeks 1-12 of the double-blind treatment period
The incidence and severity of bleeding events (Weeks 1-24)
Time frame: During Weeks 1-24 of the double-blind treatment period
The proportion of subjects who receive rescue treatment
Time frame: During the 24-week double-blind treatment period
The change of concomitant therapy
Time frame: During the 24-week double-blind treatment period
The incidence and severity of adverse events
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Related trials for Primary Immune Thrombocytopenia
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB3473 Tablets in people with Primary Immune Thrombocytopenia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 53 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hu Zhou, Doctor (13939068863, papertigerhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durable response rate: platelet counts ≥50×10^9/L (time frame: During the 24-week randomized double-blind treatment period (Weeks 14-24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.