Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
- Conditions
- Chronic Primary Immune Thrombocytopenia (ITP)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06004856
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 195
- 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).
- 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.
- Laboratory results did not meet protocol requirements.
- Pregnant or lactating women.
- Subjects whose blood cannot be collected, or who had contraindications for blood collection.
- Other conditions that were not appropriate for participation in the trial as considered by the investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Orelabrutinib Orelabrutinib -
- Primary Outcome Measures
Name Time Method Durable response rate Throughout the study period, an average of 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
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, China
Peking university People's Hospital
🇨🇳Beijing, Beijing, China
Xinqiao Hospital of Army Medical University
🇨🇳Chongqing, Chongqing, 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
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Tongji Medical College Of Hust
🇨🇳Wuhan, Hubei, China
Huazhong University of Science and Technology Union Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
North China University of Science and Technology Affiliated Hospital
🇨🇳Tangshan, Hebei, China
The Central Hospital of Yongzhou
🇨🇳Yongzhou, Hunan, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Qilu Hospital Of Shandong University Dezhou Hospital
🇨🇳Dezhou, Shandong, China
The Second People's Hospital of Yibin
🇨🇳Yibin, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang Uygur Autonomous Region, China
Zhejiang Provincial Hospital of Chinese Medicine
🇨🇳Hangzhou, Zhejiang, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Chenzhou First People's Hospital
🇨🇳Chenzhou, Hunan, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, 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
Xi'an Central Hospital
🇨🇳Xi'an, Shanxi, China
Qilu hospital of shandong university
🇨🇳Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, 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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China