Primary Immune ThrombocytopeniaPhase 2NCT07083739
A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
A Phase 2 study testing TQB3473 Tablets in people with Primary Immune Thrombocytopenia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 51 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 51 sitesChina
- Study dates
- Aug 2025to Mar 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1 :
- 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.
- Previous participation in the TQB3473-III-01 study with either: Sustained platelet count <30×10⁹/L during the 12-week pre-randomization period (<50×10⁹/L if emergency treatment was received), or completion of 24-week double-blind treatment with investigator-confirmed benefit-risk assessment favoring continued therapy.
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- Adequate major organ function as defined by protocol criteria.
- For women of childbearing potential: Must agree to use highly effective contraception from screening through 6 months after treatment completion and refrain from oocyte donation for reproductive purposes during this period; must not be breastfeeding with negative serum/urine pregnancy test within 7 days prior to enrollment. For male participants with fertile partners: Must agree to use effective contraception during the study and for 6 months thereafter.
- Cohort 2 ：
- Subjects voluntarily participate in this study upon signing the Informed Consent Form (ICF) with demonstrated compliance.
- Age ≥ 18 years (calculated from signing date of ICF); No gender restrictions; ECOG performance status score 0-1.
- Confirmed diagnosis of primary ITP >3 months prior to enrollment.
- Clinically stable condition with WHO bleeding score 0-1, no major bleeding episodes within 4 weeks pre-randomization, and investigators confirm no anticipated need for emergency treatment within 2 weeks.
- Meeting all platelet criteria: Mean platelet count <30×10⁹/L (no single value >35×10⁹/L) from ≥2 independent measurements (≥3 days apart) within 7 days pre-enrollment Confirmed platelet count <30×10⁹/L within 24 hours before enrollment.
- Documented failure or relapse after ≥1 prior standard ITP therapy.
- Adequate function of major organs per protocol definitions.
- Permitted ≤1 concurrent ITP treatment (any class), provided: Stable dose maintained for ≥4 weeks prior to enrollment (≥2 weeks for corticosteroids)
- For women of childbearing potential: Must agree to use highly effective contraception from screening through 6 months after treatment completion and refrain from oocyte donation for reproductive purposes during this period; must not be breastfeeding with negative serum/urine pregnancy test within 7 days prior to enrollment. For male participants with fertile partners: Must agree to use effective contraception during the study and for 6 months thereafter.
Who cannot join
- Cohort 1 :
- 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.
- There are multiple factors that can affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction.
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- Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major elective surgery during the study treatment period within the 4 weeks prior to enrollment
- Uncontrolled significant active infections (such as sepsis, pneumonia, or abscess), or severe infections within the 12 weeks prior to enrollment (resulting in hospitalization or requiring antibiotic treatment).
- Vaccination was administered within 8 weeks prior to enrollment, or planned during the study period.
- Received blood transfusions or blood products within 2 weeks prior to enrollment (excluding IVIg used for emergency treatment).
- Take strong CYP3A inhibitors or inducers (3 weeks for Forsythia suspensa) for 2 weeks or 5 half lives (whichever is longer) before enrollment.
- Long term/continuous treatment with drugs that affect platelet function (including but not limited to aspirin, clopidogrel, ticagrelor, NSAIDs, etc.) or anticoagulant therapy is required.
- Allergic constitution or history of severe allergies, or known allergies to the components of the investigational drug excipients.
- There are clear neurological or mental disorders, or serious psychological or mental abnormalities.
- Alcoholic or drug abusers.
- According to the researcher's perspective, other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study or interfere with the interpretation of the research results.
- It is estimated that the patient's compliance in participating in this clinical study is insufficient.
- Cohort 2：
- There is evidence to suggest the presence of secondary causes of ITP in the subjects, or immune cell depletion of two or more lineages, such as Evans syndrome;
- Past or current presence of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematological diseases.
- Have had or currently have malignant tumors within the past 3 years. The following two situations can be included in the group: other malignant tumors treated with a single surgery, 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 infiltrating basement membrane)].
- HBV DNA or HCV RNA detection values exceeding the upper limit of normal or decompensated cirrhosis.
- Previous intracranial hemorrhage or severe (≥ Common Terminology Criteria (CTC) AE grade 3) bleeding of other important organs, 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.
- There are multiple factors that can affect oral medication, such as inability to swallow, active gastric ulcers, major gastrointestinal surgeries, chronic diarrhea, and intestinal obstruction.
- ITP related symptoms and treatment:
- Received ITP emergency treatment within 2 weeks prior to enrollment;
- Received platelet transfusion within 2 weeks prior to enrollment;
- Received immunoglobulin or traditional Chinese medicine treatment within 2 weeks before enrollment;
- Used rituximab or other anti-Cluster of Differentiation 20 (CD20) drugs within 14 weeks prior to enrollment;
- Received splenectomy within 12 weeks prior to enrollment;
- Individuals who have received glucocorticoids within the 2 weeks prior to enrollment, or have received thrombopoietin drugs (rhTPO, eltrombopag, hetrombopag, avatrombopag, romiplostim), immunomodulators (azathioprine, cyclosporine A, mycophenolate mofetil), chemotherapy drugs (decitabine, vinblastine), danazol, etc. within the 4 weeks prior to enrollment, except for those who meet the inclusion criteria 8 and are allowed to undergo concomitant treatment.
- Adverse reactions from previous treatments that have not recovered to ≤ CTCAE grade 1, as well as non clinically significant and asymptomatic laboratory abnormalities that have been determined by researchers to pose no safety risks, are excluded.
- Patients who have received major surgical treatment, significant traumatic injury, or are expected to undergo major elective surgery during the study treatment period within the 4 weeks prior to enrollment (major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition).
- Vaccination was administered within 8 weeks prior to enrollment, or planned during the study period.
- Uncontrolled significant active infections (such as sepsis, pneumonia, or abscess), or severe infections within the 12 weeks prior to enrollment (resulting in hospitalization or requiring antibiotic treatment).
- Received blood transfusions or blood products within 2 weeks prior to enrollment (excluding intravenous immunoglobulin (IVIg) used for emergency treatment).
- Take strong Cytochrome P450 3A (CYP3A) inhibitors or inducers (3 weeks for Forsythia suspensa) for 2 weeks or 5 half lives (whichever is longer) before enrollment.
- Participants who have participated in and used other clinical trial drugs within 4 weeks prior to enrollment.
- Long term/continuous treatment with drugs that affect platelet function (including but not limited to aspirin, clopidogrel, ticagrelor, NSAIDs, etc.) or anticoagulant therapy is required.
- Allergic constitution or history of severe allergies, or known allergies to the components of the investigational drug excipients.
- History of important organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- History of immunodeficiency, including HIV positivity or other congenital immunodeficiency diseases.
- Individuals with epilepsy who require treatment.
- There are clear neurological or mental disorders, or serious psychological or mental abnormalities.
- Alcoholic or drug abusers.
- According to the researcher's perspective, other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study or interfere with the interpretation of the research results.
- It is estimated that the patient's compliance in participating in this clinical study is insufficient.
Trial locations and contacts
51 sites in 1 country. Contact the study team or a site near you to ask about taking part.
51 sites in 1 country
China51 sites
Anyang People's Hospital
Anyang, Henan, 455112
Zhengrong Liu, Doctor, 13837203600, 13837203600@139.com
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, 071000
Hua Xue, Doctor, 15031273319, xh-xuehua@163.com
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Aijun Liu, Doctor, 13521030376, laj0628@163.com
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Tienan Zhu, Doctor, 18611743292, zhutn@pumch.cn
The first hospital of Jilin University
Changchun, Jilin, 130400
Sujun Gao, Doctor, 15843073208, sujung1963@sina.com
The Third Hospital of Changsha
Changsha, Hunan, 410035
Zengmei Sheng, Master, 13308458926, shengzengmei@163.com
Heping Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000
Xuliang Shen, Doctor, 13015365546, shenxlcyp@sohu.com
Affiliated Hospital of ChengDe Medical University
Chengde, Hebei, 067000
Zhihua Zhang, Master, 15633142905, zzhangzhihua@163.com
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Hanqing Zeng, Doctor, 18523394870, 233318983@qq.com
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001
Xiangzhou Du, Bachelor, 13576686139, jxdxz1989@163.com
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jieyu Ye, Doctor, 18988932111, jieyu.ye@gmail.com
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Jishi Wang, Doctor, 13639089646, Wangjishi9646@163.com
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Lu Xu, Doctor, 13518073033, xulu2324@163.com
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310006
Qinghong Yu, Doctor, 13575758729, ealeyu@126.com
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Shengjin Fan, Doctor, 13304641978, fansj1129@sohu.com
The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, 230001
Changcheng Zheng, Doctor, 18956073079, zhengchch1123@163.com
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Ming Hou, Doctor, 18560087028, houming@medmail.com
Shandong First Medical University Affiliated Central Hospital
Jinan, Shandong, 250013
Yun Chen, Doctor, 13370582720, chyun008@163.com
Kunming Medical University Second Affiliated Hospital
Kunming, Yunnan, 650033
Zepin Zhou, Doctor, 18788571605, 1580837415@qq.com
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Yaming Xi, Doctor, 13919110815, xiyaming02@163.com
Linyi Central Hospital
Linyi, Shandong, 276401
Guitao Jie, Master, 13869997389, guitaojie@126.com
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006
Fei Li, Doctor, 13970038386, yx021021@sina.com
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Rongfu Zhou, Doctor, 13605142342, rfzhoucn@163.com
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangsheng He, Doctor, 15312052798, heguangsheng1972@sina.com
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530005
Yinghui Lai, Doctor, 13977187876, yinghuilai@sina.com
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006
Lu Zhou, Doctor, 18761720268, xueyezhoulu2007@sina.com
Nanyang Central Hospital
Nanyang, Henan, 473001
Chao Li, Bachelor, 18336637929, 18336637929@163.com
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Yongcheng Sun, Master, 15767800004, sunyc1983@126.com
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030
Chunkang Chang, Doctor, 13764643870, changchunkang7010@aliyun.com
Affiliated Zhongshan Hospital of Fudan University, Qingpu Branch
Shanghai, Shanghai Municipality, 201700
Fanli Hua, Doctor, 18116017032, huafanli@163.com
Shenjing Hospital Of China Medical University
Shenyang, Liaoning, 110000
Aijun Liao, Doctor, 18940259833, liaoaijun@sina.com
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, 518000
Zhi Guo, Doctor, 13671053558, guozhi77@126.com
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023
Huiming Zhang, Doctor, 18633889276, zhanghuimina@sina.com
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Shaolong He, Master, 19935261898, hsl393@163.com
North China University of science and technology
Tangshan, Hebei, 063000
Zhenyu Yan, Doctor, 18831508262, hbyzy2011@163.com
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070
Rong Fu, Doctor, 13920350233, furong8369@tmu.edu.cn
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
Xingli Zhao, Doctor, 13752255454, tjsrmyyxyk@163.com
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000
Yan Li, Master, 13639935315, 1iyan232917@sina.com
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Xinhong Guo, 15292898288, guoxinhong222@sina.cn
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Heng Mei, Doctor, 13886160811, mayheng@126.com
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Fuling Zhou, Doctor, 18986265580, zhoufuling@163.com
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
Hesheng He, Master, 15255378879, hhsmed2012@126.com
Xijing Hospital
Xi'an, Shaanxi, 710000
Guangxun Gao, Doctor, 13991907320, Gaoguangxun@fmmu.edu.cn
Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018
Xiequn Chen, Doctor, 13991832567, Cxq@nwu.edu.cn
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Pengcheng He, Doctor, 18991232609, Hepc_gcp@163.com
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Hui Geng, Master, 13519775270, gh0227@sina.com
Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
Yantai, Shandong, 264099
Junjie Ma, Master, 18660487687, mjjshj@sina.com
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, 524045
Guocai Wu, Master, 13553564019, deanwgc@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
LiuLiu Liu, Doctor, 15936230382, liuliuxx1983@163.com
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Hu Zhou, Doctor, 13939068863, papertigerhu@163.com
The First People's Hospital of Ping Ding Shan
Zhengzhou, Henan, 450003
Zhanfang Wang, Master, 13393798910, pdssyyllb@126.com
About this study
Official title: Phase II Clinical Trial on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
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.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- TQB3473 Tablets
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TQB3473 Tablets | Experimental | TQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks. Receives: Drug: TQB3473 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 13-24
Secondary outcomes (26)
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);
Measured: 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).
Measured: Within 24 weeks of treatment
Time to Onset
The time from the initiation of treatment to the first platelet count ≥50×10^9/L
Measured: 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.
Measured: Within 24 weeks of treatment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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-∞)
Measured: Within 24 weeks of treatment
Maximum plasma concentration (Cmax) after initial administration
Maximum plasma concentration (Cmax) after initial administration.
Measured: Within 24 weeks of treatment
Elimination Half-Life（t1/2）after initial administration
Elimination Half-Life（t1/2）after initial administration.
Measured: Within 24 weeks of treatment
Apparent clearance（CL/F）after initial administration
Apparent clearance（CL/F）after initial administration.
Measured: 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.
Measured: Within 24 weeks of treatment
Terminal elimination Rate Constant (λz) after initial administration
Terminal elimination Rate Constant (λz) after initial administration.
Measured: 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).
Measured: 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-∞).
Measured: Within 24 weeks of treatment
Minimum steady-state concentration (Css-min) after multiple administration
Minimum steady-state concentration (Css-min) after multiple administration.
Measured: Within 24 weeks of treatment
Maximum steady-state concentration (Css-max) after multiple administration
Maximum steady-state concentration (Css-max) after multiple administration.
Measured: Within 24 weeks of treatment
Average Steady-State Concentration (Css-avg) after multiple administration
Average Steady-State Concentration (Css-avg) after multiple administration.
Measured: Within 24 weeks of treatment
Elimination Half-Life (t1/2) after multiple administration
Elimination Half-Life (t1/2) after multiple administration.
Measured: Within 24 weeks of treatment
Apparent Clearance (CL/F) after multiple administration
Apparent Clearance (CL/F) after multiple administration.
Measured: 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).
Measured: Within 24 weeks of treatment
Terminal Elimination Rate Constant (λz) after multiple administration
Terminal Elimination Rate Constant (λz) after multiple administration.
Measured: Within 24 weeks of treatment
Accumulation ratio constant (Rac) after multiple administration
Accumulation ratio constant (Rac) after multiple administration.
Measured: Within 24 weeks of treatment
Degree of fluctuation (DF) after multiple administration
Degree of fluctuation (DF) after multiple administration.
Measured: Within 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 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
- NCT07083739
- Sponsor's protocol ID
- TQB3473-II-01
- Status last verified
- May 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
- ClinicalTrials.gov ID
- NCT07083739
- Acronym / sponsor ID
- TQB3473-II-01
- Conditions
- Primary Immune Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jul 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3473 Tablets | Experimental | Drug: TQB3473 TabletsTQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Previous participation in the TQB3473-III-01 study with either: Sustained platelet count <30×10⁹/L during the 12-week pre-randomization period (<50×10⁹/L if emergency treatment was received), or completion of 24-week double-blind treatment with investigator-confirmed benefit-risk assessment favoring continued therapy.
Key exclusion criteria (48 listed)
- Cohort 1 :
- Cohort 2：
- There is evidence to suggest the presence of secondary causes of ITP in the subjects, or immune cell depletion of two or more lineages, such as Evans syndrome;
- Past or current presence of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematological diseases.
- Have had or currently have malignant tumors within the past 3 years. The following two situations can be included in the group: other malignant tumors treated with a single surgery, 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 infiltrating basement membrane)].
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 |
Primary outcome
Sustained response rate
Time frame: Weeks 13-24
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).
26 secondary outcomes
Response rate at 12 weeks
Time frame: Within 12 weeks of treatment
Response rate at 24 weeks
Time frame: Within 24 weeks of treatment
Time to Onset
Time frame: 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
The proportion of subjects who receive rescue treatment
Time frame: Within 24 weeks of treatment
The incidence and severity of bleeding events
Time frame: Within 24 weeks of treatment
The change of concomitant therapy
Time frame: Within 24 weeks of treatment
Improvement in Quality of Life Score
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.
Time frame: Within 24 weeks of treatment
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
Time frame: Within 24 weeks of treatment
Elimination Half-Life（t1/2）after initial administration
Time frame: Within 24 weeks of treatment
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
Time frame: Within 24 weeks of treatment
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)
Time frame: Within 24 weeks of treatment
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
Time frame: Within 24 weeks of treatment
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
Time frame: Within 24 weeks of treatment
Elimination Half-Life (t1/2) after multiple administration
Time frame: Within 24 weeks of treatment
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)
Time frame: Within 24 weeks of treatment
Terminal Elimination Rate Constant (λz) after multiple administration
Time frame: Within 24 weeks of treatment
Accumulation ratio constant (Rac) after multiple administration
Time frame: Within 24 weeks of treatment
Degree of fluctuation (DF) after multiple administration
Time frame: Within 24 weeks of treatment
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 24 Jul 2025.
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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.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB3473 Tablets in people with Primary Immune Thrombocytopenia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 51 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 18 inclusion and 48 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: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sustained response rate (time frame: Weeks 13-24). 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 24 Jul 2025.