Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
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
1 other identifier
interventional
195
1 country
45
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2023
Typical duration for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 22, 2023
CompletedStudy Start
First participant enrolled
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedMay 13, 2024
May 1, 2024
2.2 years
August 15, 2023
May 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Durable response rate
Throughout the study period, an average of 6 months
Study Arms (2)
Orelabrutinib
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study.
- Males or females aged from 18 to 80 years (including the marginal values).
- With a body weight of ≥ 35 kg at screening.
- In accordance with the diagnosis of chronic (≥ 12 months) ITP
- 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.
- 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).
You may not qualify if:
- Severe hemorrhage occurred within 4 weeks prior to screening.
- Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator.
- 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.
- Subjects had multiple immune hemocytopenia.
- Subjects had inherited thrombocytopenia or secondary ITP.
- Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening.
- Received prohibited medications within protocol-specified period before the first dose.
- Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug.
- 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).
- 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.
- 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.
- Received splenectomy and had a prior history of overwhelming post-splenectomy infection (OPSI).
- Had a history of alcohol or drug abuse currently or within the past 1 year, excepting nicotine and caffeine.
- Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month prior to screening or during the screening period.
- Previous exposure to BTK inhibitors.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing CHAO-YANG Hospital Capital Medcal University
Beijing, Beijing Municipality, 100044, China
Peking university People's Hospital
Beijing, Beijing Municipality, 100044, China
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400000, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361004, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong, 518052, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450004, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Medical College Of Hust
Wuhan, Hubei, 430030, China
Yichang Central People's Hospital
Yichang, Hubei, 443008, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Chenzhou First People's Hospital
Chenzhou, Hunan, 423003, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425006, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The first Hospital of China Medical University
Shenyang, Liaoning, 110002, China
Qilu Hospital Of Shandong University Dezhou Hospital
Dezhou, Shandong, 253000, China
Qilu hospital of shandong university
Jinan, Shandong, 250012, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Xi'an Central Hospital
Xi’an, Shanxi, 710003, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710061, China
Shaanxi Provincial People'S Hospital
Xi’an, Shanxi, 710068, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000, China
The Affilated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2023
First Posted
August 22, 2023
Study Start
October 26, 2023
Primary Completion
December 31, 2025
Study Completion
April 30, 2026
Last Updated
May 13, 2024
Record last verified: 2024-05