Actively Recruiting
A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-05-20
199
Participants Needed
53
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance
- Male or female subjects aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) score of 0-1
- Diagnosed with primary ITP for at least 12 months
- Average platelet count below 30×10^9/L in at least three counts within the 3 months before randomization, with no count above 35×10^9/L
- No severe bleeding within 4 weeks prior to screening
- Previously treated 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, with a negative pregnancy test within 7 days prior to enrollment
- Male subjects must agree to use effective contraception during the study and for 6 months after
You will not qualify if you...
- Evidence of secondary causes of ITP or drug-induced causes
- History or current diagnosis of myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative disorders, or other malignant hematologic diseases
- History of or other malignancies within the past 3 years, except certain treated and cured cancers
- Conditions affecting venous blood sampling or oral medication intake
- Unresolved adverse reactions from previous treatments above grade 1 except minor lab abnormalities
- Previous bone marrow or major organ transplant
- Vaccination within 8 weeks prior to randomization or planned vaccination during study
- Major surgery or significant trauma within 4 weeks prior to randomization or planned major surgery during study
- History of severe bleeding in vital organs or symptomatic gastrointestinal bleeding within 6 months prior to screening
- Arterial or venous thrombotic events within 12 months prior to randomization
- Receipt of immunoglobulins, platelet transfusions, or treatments increasing platelet counts within specified timeframes prior to randomization
- Use of rituximab or other anti-CD20 drugs within 14 weeks prior to randomization
- Splenectomy within 12 weeks prior to randomization
- Need for long-term medications affecting platelet function or anticoagulant therapy
- Known allergy to study drug ingredients
- Previous treatment with Syk inhibitors
- Participation in another clinical trial with investigational drugs within 4 weeks prior to randomization
- Any condition posing significant safety risk or affecting ability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
The first affiliated hospital of ustc anhui provincial hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
Not Yet Recruiting
3
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
5
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
6
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
7
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
8
Shenzhen Nanshan People's Hospital
Shenzhen, Guangdong, China, 518000
Not Yet Recruiting
9
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China, 524045
Not Yet Recruiting
10
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530005
Not Yet Recruiting
11
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Not Yet Recruiting
12
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570102
Not Yet Recruiting
13
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, China, 071000
Actively Recruiting
14
Affiliated Hospital of ChengDe Medical University
Chengde, Hebei, China, 067000
Not Yet Recruiting
15
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050023
Not Yet Recruiting
16
North China University of science and technology
Tangshan, Hebei, China, 063000
Not Yet Recruiting
17
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
18
Anyang People's Hospital
Anyang, Henan, China, 455112
Not Yet Recruiting
19
Nanyang Central Hospital
Nanyang, Henan, China, 473001
Not Yet Recruiting
20
Xuchang Central Hospital
Xuchang, Henan, China, 461000
Not Yet Recruiting
21
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
22
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
23
The First People's Hospital of Ping Ding Shan
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
24
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
25
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Not Yet Recruiting
26
The Third Hospital of Changsha
Changsha, Hunan, China, 410035
Not Yet Recruiting
27
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
28
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
29
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226006
Not Yet Recruiting
30
Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Yangzhou, Jiangsu, China, 225009
Not Yet Recruiting
31
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341001
Not Yet Recruiting
32
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
33
The first hospital of Jilin University
Changchun, Jilin, China, 130400
Not Yet Recruiting
34
Shenjing Hospital Of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
35
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000
Not Yet Recruiting
36
Xijing Hospital
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
37
Xi'an No.3 Hospital
Xi'an, Shaanxi, China, 710018
Not Yet Recruiting
38
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
39
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Not Yet Recruiting
40
Shandong First Medical University Affiliated Central Hospital
Jinan, Shandong, China, 250013
Not Yet Recruiting
41
Linyi Central Hospital
Linyi, Shandong, China, 276401
Not Yet Recruiting
42
Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
Yantai, Shandong, China, 264099
Not Yet Recruiting
43
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
44
Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch
Shanghai, Shanghai Municipality, China, 201700
Not Yet Recruiting
45
Heping Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, China, 046000
Not Yet Recruiting
46
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
47
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300070
Not Yet Recruiting
48
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300121
Not Yet Recruiting
49
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China, 830000830000
Not Yet Recruiting
50
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
51
Kunming Medical University Second Affiliated Hospital
Kunming, Yunnan, China, 650033
Not Yet Recruiting
52
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
53
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315020
Not Yet Recruiting
Research Team
H
Hu Zhou, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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