Actively Recruiting
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2024-05-13
195
Participants Needed
45
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune Thrombocytopenia
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate by signing informed consent
- Male or female aged 18 to 80 years
- Body weight of at least 35 kg at screening
- Diagnosed with chronic immune thrombocytopenia lasting 12 months or more
- Previously treated with at least one standard anti-ITP treatment (glucocorticoids and/or intravenous immunoglobulin) but with inadequate response, intolerance, relapse, or loss of efficacy
- Females of childbearing potential must use effective contraception during screening, the trial, and for 90 days after last dose
You will not qualify if you...
- Severe bleeding within 4 weeks before screening
- Severe immune thrombocytopenia at screening as judged by investigator
- Autoimmune systemic diseases other than ITP that affect study evaluation
- Multiple immune hemocytopenia
- Inherited thrombocytopenia or secondary ITP
- History of arterial or venous blood clots within 6 months before screening
- Use of prohibited medications in the specified period before dosing
- Blood or platelet transfusions within 2 weeks prior to first dose
- Participation in another investigational drug or device study within 30 days or 5 half-lives prior to screening
- Recent use or planned use of strong CYP3A inhibitors or inducers within 14 days before first dose or during study
- Major surgery or trauma within 28 days before first dose or planned during treatment
- History of overwhelming post-splenectomy infection after splenectomy
- Alcohol or drug abuse within past year
- COVID-19 or live vaccine within 1 month before or during screening
- Previous treatment with BTK inhibitors
- Laboratory test results not meeting protocol requirements
- Pregnancy or breastfeeding
- Unable to have blood collected or contraindications to blood collection
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233004
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
3
Beijing CHAO-YANG Hospital Capital Medcal University
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
4
Peking university People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
5
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 400000
Not Yet Recruiting
6
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
7
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361004
Not Yet Recruiting
8
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Not Yet Recruiting
9
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
10
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
11
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, China, 518052
Actively Recruiting
12
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
13
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
14
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
15
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Actively Recruiting
16
Henan Cancer Hospital
Zhengzhou, Henan, China, 450004
Actively Recruiting
17
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
18
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
19
Tongji Medical College Of Hust
Wuhan, Hubei, China, 430030
Not Yet Recruiting
20
Yichang Central People's Hospital
Yichang, Hubei, China, 443008
Actively Recruiting
21
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
22
Chenzhou First People's Hospital
Chenzhou, Hunan, China, 423003
Actively Recruiting
23
The Central Hospital of Yongzhou
Yongzhou, Hunan, China, 425006
Actively Recruiting
24
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010000
Not Yet Recruiting
25
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
26
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
27
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214000
Actively Recruiting
28
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Actively Recruiting
29
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
30
The first Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Not Yet Recruiting
31
Qilu Hospital Of Shandong University Dezhou Hospital
Dezhou, Shandong, China, 253000
Not Yet Recruiting
32
Qilu hospital of shandong university
Jinan, Shandong, China, 250012
Actively Recruiting
33
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200020
Not Yet Recruiting
34
Xi'an Central Hospital
Xi’an, Shanxi, China, 710003
Actively Recruiting
35
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
36
Shaanxi Provincial People'S Hospital
Xi’an, Shanxi, China, 710068
Actively Recruiting
37
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
38
The Affilated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
39
The Second People's Hospital of Yibin
Yibin, Sichuan, China, 644000
Not Yet Recruiting
40
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
41
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Not Yet Recruiting
42
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
Not Yet Recruiting
43
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650000
Actively Recruiting
44
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
45
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
A
Alexia Lu
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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