Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
NCT ID: NCT06004856
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
195 participants
INTERVENTIONAL
2023-10-26
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Orelabrutinib
Orelabrutinib
Orelabrutinib once daily (QD)
Placebo
Placebo
Placebo once daily (QD)
Interventions
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Orelabrutinib
Orelabrutinib once daily (QD)
Placebo
Placebo once daily (QD)
Eligibility Criteria
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Inclusion Criteria
2. Males or females aged from 18 to 80 years (including the marginal values).
3. With a body weight of ≥ 35 kg at screening.
4. In accordance with the diagnosis of chronic (≥ 12 months) ITP
5. Patients who have previously received at least one anti-ITP first-line standard treatment (glucocorticoids and/or intravenous immunoglobulin) cannot maintain efficacy, or relapse, or cannot tolerate standard treatment, or have insufficient response.
6. Females of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days after the last administration of the investigational medicinal product (IMP).
Exclusion Criteria
2. Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator.
3. Subjects had autoimmune systemic diseases other than ITP unless they would not affect the evaluation of the study results in the judgment of the investigator and sponsor medical monitor.
4. Subjects had multiple immune hemocytopenia.
5. Subjects had inherited thrombocytopenia or secondary ITP.
6. Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening.
7. Received prohibited medications within protocol-specified period before the first dose.
8. Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug.
9. Participated in another study of the investigational drug (and/or investigational device) within 30 days or within 5 half-lives prior to screening (whichever is longer), or is currently participating in another study of the investigational drug (and /or investigational device).
10. The last administration of strong CYP3A inhibitors or strong CYP3A inducers (include food, western medicine, traditional Chinese medicine) is within 14 days (or 5 half-lives, whichever is longer) prior to the first dose, or planned to take a drug or food with a strong inhibition or induction of CYP3A during the study period.
11. Received a major surgery (including splenectomy) or trauma (except biopsy) within 28 days prior to the first dose of the investigational drug, or expected to receive a major surgery during the study treatment period.
12. Received splenectomy and had a prior history of overwhelming post-splenectomy infection (OPSI).
13. Had a history of alcohol or drug abuse currently or within the past 1 year, excepting nicotine and caffeine.
14. Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month prior to screening or during the screening period.
15. Previous exposure to BTK inhibitors.
16. Laboratory results did not meet protocol requirements.
17. Pregnant or lactating women.
18. Subjects whose blood cannot be collected, or who had contraindications for blood collection.
19. Other conditions that were not appropriate for participation in the trial as considered by the investigators.
18 Years
80 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing CHAO-YANG Hospital Capital Medcal University
Beijing, Beijing Municipality, China
Peking university People's Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Medical College Of Hust
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital Of Shandong University Dezhou Hospital
Dezhou, Shandong, China
Qilu hospital of shandong university
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xi'an Central Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China
Shaanxi Provincial People'S Hospital
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Affilated Hospital of Southwest Medical University
Luzhou, Sichuan, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Feng Zhang
Role: primary
Qingshu Zeng
Role: primary
Wenming Chen
Role: primary
Xiaohui Zhang
Role: primary
Yimei Feng
Role: primary
Fenge Yang
Role: primary
Bing Xu
Role: primary
Quanyi Lu
Role: primary
Qike Zhang
Role: primary
Jing Sun
Role: primary
Zhi Guo
Role: primary
Jingyu Zhang
Role: primary
Zhenyu Yan
Role: primary
Wei Wang
Role: primary
Ling Qin
Role: primary
Hu Zhou
Role: primary
Fang Wang
Role: primary
Heng Mei
Role: primary
Dengju Li
Role: primary
Jingming Guo
Role: primary
Yajing Xu
Role: primary
Xinquan Liang
Role: primary
Shibin Deng
Role: primary
Da Guo
Role: primary
Rongfu Zhou
Role: primary
Guangsheng He
Role: primary
Xin Zhou
Role: primary
Chenghao Jin
Role: primary
Ruibin Huang
Role: primary
Xiaojing Yan
Role: primary
Lin Wang
Role: primary
Junmin Li
Role: primary
Yanping Song
Role: primary
Pengcheng He
Role: primary
Yi Wang
Role: primary
Rong Xiao
Role: primary
Xiaoming Li
Role: primary
Shihua Huang
Role: primary
Lei Zhang
Role: primary
Rong Fu
Role: primary
Xinhong Guo
Role: primary
Zeping Zhou
Role: primary
Jie Jin
Role: primary
Baodong Ye
Role: primary
Other Identifiers
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ICP-CL-00126
Identifier Type: -
Identifier Source: org_study_id
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