A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia

May 18, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • The First Affiliated Hospital of USTC Anhui Provincial Hospital
        • Contact:
      • Wuhu, Anhui, China, 241001
        • Not yet recruiting
        • The First Affiliated Hospital of Wannan Medical College
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100020
        • Not yet recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Not yet recruiting
        • Shenzhen Nanshan People's Hospital
        • Contact:
      • Zhanjiang, Guangdong, China, 524045
        • Not yet recruiting
        • Central People's Hospital of Zhanjiang
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530005
        • Not yet recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570102
        • Not yet recruiting
        • The First Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • Affiliated Hospital of Hebei University / School of Clinical Medicine
        • Contact:
      • Chengde, Hebei, China, 067000
        • Not yet recruiting
        • Affiliated Hospital of Chengde Medical University
        • Contact:
      • Shijiazhuang, Hebei, China, 050023
        • Not yet recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
      • Tangshan, Hebei, China, 063000
        • Not yet recruiting
        • North China University of Science and Technology
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Not yet recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Anyang, Henan, China, 455112
        • Not yet recruiting
        • Anyang People's Hospital
        • Contact:
      • Nanyang, Henan, China, 473001
        • Not yet recruiting
        • Nanyang Central Hospital
        • Contact:
      • Xuchang, Henan, China, 461000
        • Not yet recruiting
        • Xuchang Central Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • The First People'S Hospital of Ping Ding Shan
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410035
        • Not yet recruiting
        • The Third Hospital of Changsha
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nantong, Jiangsu, China, 226006
        • Not yet recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
      • Yangzhou, Jiangsu, China, 225009
        • Not yet recruiting
        • Northern Jiangsu People's Hospital Affiliated to Yangzhou University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341001
        • Not yet recruiting
        • Ganzhou People's Hospital
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130400
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Shenjing Hospital of CHINA MEDICAL UNIVERSITY
        • Contact:
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Not yet recruiting
        • Qinghai University Affiliated Hospital
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital Of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • Xijing Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710018
        • Not yet recruiting
        • Xi'an No.3 Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250013
        • Not yet recruiting
        • Shandong First Medical University Affiliated Central Hospital
        • Contact:
      • Linyi, Shandong, China, 276401
        • Not yet recruiting
        • Linyi Central Hospital
        • Contact:
      • Yantai, Shandong, China, 264099
        • Not yet recruiting
        • Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
      • Shanghai, Shanghai, China, 201700
        • Not yet recruiting
        • Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Not yet recruiting
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
      • Taiyuan, Shanxi, China, 030032
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300070
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300121
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
      • Ürümqi, Xinjiang, China, 830000830000
        • Not yet recruiting
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650033
        • Not yet recruiting
        • Kunming Medical University Second Affiliated Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
      • Ningbo, Zhejiang, China, 315020
        • Not yet recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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:

    1. Receipt of immunoglobulins or platelet transfusions within 2 weeks prior to randomization;
    2. 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);
    3. Use of rituximab or other anti-cluster of differentiation 20 (CD20) drugs within 14 weeks prior to randomization;
    4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TQB3473 Tablets
TQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks.
Drug: TQB3473 Tablets
TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.
Placebo Comparator: TQB3473 Placebo
Placebo, orally once daily for 24 consecutive weeks.
Drug: TQB3473 Placebo
Placebo contains no active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During the 24-week randomized double-blind treatment period (Weeks 14-24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness rate within the first 12 weeks of treatment
Time Frame: Baseline to 12 weeks
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).
Baseline to 12 weeks
The response rate within 24 weeks of treatment
Time Frame: 24 weeks

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
Time Frame: The time from the initiation of treatment to the first platelet count ≥50×10^9/L (excluding rescue treatment)
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)
Time Frame: During Weeks 1-12 of the double-blind treatment period
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)
Time Frame: During Weeks 1-24 of the double-blind treatment period
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
Time Frame: During the 24-week double-blind treatment period
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
Time Frame: During the 24-week double-blind treatment period
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 18, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB3473-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Immune Thrombocytopenia

Clinical Trials on TQB3473 Tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe