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)

Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 after at least one standard ITP treatment. The study consists of a treatment period and a safety follow-up period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Anyang People's Hospital
NOT_YET_RECRUITING
Anyang
Affiliated Hospital of Hebei University / School of Clinical Medicine
RECRUITING
Baoding
Beijing Chaoyang Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
The first hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Third Hospital of Changsha
NOT_YET_RECRUITING
Changsha
Heping Hospital affiliated to Changzhi Medical College
NOT_YET_RECRUITING
Changzhi
Affiliated Hospital of ChengDe Medical University
NOT_YET_RECRUITING
Chengde
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Ganzhou People's Hospital
NOT_YET_RECRUITING
Ganzhou
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
The First Affiliated Hospital of Hainan Medical University
NOT_YET_RECRUITING
Haikou
The First Affiliated Hospital of Zhejiang Chinese Medical University
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The first affiliated hospital of ustc anhui provincial hospital
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong First Medical University Affiliated Central Hospital
NOT_YET_RECRUITING
Jinan
Kunming Medical University Second Affiliated Hospital
NOT_YET_RECRUITING
Kunming
The First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
Linyi Central Hospital
NOT_YET_RECRUITING
Linyi
The First Affiliated Hospital of NanChang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
The Second Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Nantong University
NOT_YET_RECRUITING
Nantong
Nanyang Central Hospital
NOT_YET_RECRUITING
Nanyang
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Affiliated Zhongshan Hospital of Fudan University,Qingpu Branch
NOT_YET_RECRUITING
Shanghai
Shanghai Sixth People's Hospital
NOT_YET_RECRUITING
Shanghai
Shenjing Hospital Of China Medical University
NOT_YET_RECRUITING
Shenyang
Shenzhen Nanshan People's Hospital
NOT_YET_RECRUITING
Shenzhen
The First Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
North China University of science and technology
NOT_YET_RECRUITING
Tangshan
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin People's Hospital
NOT_YET_RECRUITING
Tianjin
People's Hospital of Xinjiang Uygur Autonomous Region
NOT_YET_RECRUITING
Ürümqi
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Xi'an No.3 Hospital
NOT_YET_RECRUITING
Xi'an
Xijing Hospital
NOT_YET_RECRUITING
Xi'an
Qinghai University Affiliated Hospital
NOT_YET_RECRUITING
Xining
Xuchang Central Hospital
NOT_YET_RECRUITING
Xuchang
Northern Jiangsu People's Hospital Affiliated to Yangzhou University
NOT_YET_RECRUITING
Yangzhou
Yantai Yuhuangding Hospital (Affiliated Yantai Yuhuangding Hospital of Qingdao University)
NOT_YET_RECRUITING
Yantai
Central People's Hospital of Zhanjiang
NOT_YET_RECRUITING
Zhanjiang
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
The First People's Hospital of Ping Ding Shan
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Hu Zhou, Doctor
papertigerhu@163.com
13939068863
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 199
Treatments
Active_comparator: TQB3473 Tablets
TQB3473 Tablets 600 mg orally once daily for 24 consecutive weeks.
Placebo_comparator: TQB3473 Placebo
Placebo, orally once daily for 24 consecutive weeks.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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