A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults
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
1 other identifier
interventional
320
1 country
51
Brief 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. This is a single arm, open label, multi cohort, multi center Phase II clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 24, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
July 24, 2025
May 1, 2025
2.1 years
July 16, 2025
July 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Weeks 13-24
Secondary Outcomes (26)
Response rate at 12 weeks
Within 12 weeks of treatment
Response rate at 24 weeks
Within 24 weeks of treatment
Time to Onset
Within 24 weeks of treatment
The cumulative duration of platelet count ≥ 50 × 10^9/L within 24 weeks of treatment
Within 24 weeks of treatment
The proportion of subjects who receive rescue treatment
Within 24 weeks of treatment
- +21 more secondary outcomes
Study Arms (1)
TQB3473 Tablets
EXPERIMENTALTQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks.
Interventions
TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +3 more criteria
You may not qualify if:
- 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.
- 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.
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, 518000, China
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, 524045, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530005, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, 071000, China
Affiliated Hospital of ChengDe Medical University
Chengde, Hebei, 067000, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023, China
North China University of science and technology
Tangshan, Hebei, 063000, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Anyang People's Hospital
Anyang, Henan, 455112, China
Nanyang Central Hospital
Nanyang, Henan, 473001, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First People's Hospital of Ping Ding Shan
Zhengzhou, Henan, 450003, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
The Third Hospital of Changsha
Changsha, Hunan, 410035, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226006, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin University
Changchun, Jilin, 130400, China
Shenjing Hospital Of China Medical University
Shenyang, Liaoning, 110000, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000, China
Xijing Hospital
Xi'an, Shaanxi, 710000, China
Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Shandong First Medical University Affiliated Central Hospital
Jinan, Shandong, 250013, China
Linyi Central Hospital
Linyi, Shandong, 276401, China
Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
Yantai, Shandong, 264099, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200030, China
Affiliated Zhongshan Hospital of Fudan University, Qingpu Branch
Shanghai, Shanghai Municipality, 201700, China
Heping Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Kunming Medical University Second Affiliated Hospital
Kunming, Yunnan, 650033, China
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310006, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2025
First Posted
July 24, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
July 24, 2025
Record last verified: 2025-05